[
{"id":"NCT07771426","registry":"ClinicalTrials.gov","slug":"the-spark-pmdd-study-nct07771426","match":"direct","title":"The SPARK-PMDD Study","official_title":"Studying Psychological Changes And inflammatoRy marKers in Premenstrual Dysphoric Disorder (PMDD)","acronym":"SPARK-PMDD","status":"NOT_YET_RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Dysphoric Disorder","PMDD","Premenstrual Dysphoric Disorder ( PMDD)","Premenstrual Dysphoric Disorder (PMDD)"],"keywords":["menstrual cycle","pmdd","luteal phase","womens health","reproductive health","reproductive mental health","inflammation","stress","premenstrual","female"],"interventions":[],"sponsor":"King's College London","sponsor_class":"OTHER","collaborators":["South London and Maudsley NHS Foundation Trust"],"countries":["United Kingdom"],"enrollment":120,"enrollment_type":"ESTIMATED","start_date":"2027-01-01","completion_date":"2029-10-01","first_posted":"2026-08-18","last_update":"2026-08-18","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07771426","reference_pmids":[],"brief_summary":"Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of \"hyperactivity\" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. This response is referred to as inflammation. This discovery has unveiled unique opportunities to identify new medications to help patients with this heightened inflammation who have also not been responding to their antidepressant medications. This study aims to explore how inflammation in the body may be linked to symptoms of Premenstrual Dysphoric Disorder (PMDD) across the menstrual cycle, and how thoughts, emotions, and behaviours also may change throughout the cycle. We are recruiting two groups of people: People with a clinical or provisional (suspected) diagnosis of PMDD, and healthy controls who experience mild/no premenstrual changes. Over a two-month period, participants will complete daily psychological assessments across two menstrual cycles and will come into King's College Hospital (KCH) twice during one menstrual cycle to provide blood samples to measure their inflammation. By comparing these groups, we hope to gain a better understanding of the biological and psychological factors involved in PMDD, with the long-term goal of improving treatment options."},
{"id":"NCT07818720","registry":"ClinicalTrials.gov","slug":"mls101-study-in-pmdd-nct07818720","match":"direct","title":"MLS101 Study in PMDD","official_title":"A Phase 1b Study to Evaluate the Safety and Tolerability of MLS101 Treatment for Premenstrual Dysphoric Disorder (PMDD)","acronym":null,"status":"NOT_YET_RECRUITING","phases":["PHASE1"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder ( PMDD)","PMDD"],"keywords":["PMDD","PMS","Premenstrual Dysphoric Disorder","psilocybin"],"interventions":[{"type":"DRUG","name":"MLS101 psilocybin"},{"type":"DRUG","name":"Placebo capsules"}],"sponsor":"MycoMedica Life Sciences PBC","sponsor_class":"INDUSTRY","collaborators":[],"countries":[],"enrollment":32,"enrollment_type":"ESTIMATED","start_date":"2026-12","completion_date":"2027-12","first_posted":"2026-09-14","last_update":"2026-09-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07818720","reference_pmids":[],"brief_summary":"The goal of this clinical trial is to learn if MLS101 (psilocybin) is a possible treatment for women with Premenstrual Dysphoric Disorder (PMDD). The main question it aims to answer is: • Test the safety and tolerability of the study drug, MLS101 in premenopausal women (ages 18-50 inclusive) with PMDD."},
{"id":"NCT07785622","registry":"ClinicalTrials.gov","slug":"the-effect-of-mandala-coloring-sleep-quality-anxiety-with-nct07785622","match":"direct","title":"The Effect of Mandala Coloring, Sleep Quality, Anxiety With Premenstrual Syndrome","official_title":"The Effect of Mandala Coloring on Sleep Quality and Anxiety Levels in Students With Premenstrual Syndrome","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Mandala coloring","Anxiety","Sleep Disorder"],"interventions":[{"type":"OTHER","name":"Mandala coloring group"}],"sponsor":"Kırklareli University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":80,"enrollment_type":"ESTIMATED","start_date":"2026-11-01","completion_date":"2027-06-30","first_posted":"2026-08-25","last_update":"2026-08-25","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07785622","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is a common condition among women of reproductive age and is characterized by a range of physical, psychological, and behavioral symptoms that may negatively affect daily functioning, social relationships, academic and occupational life, and psychological well-being. Anxiety and sleep disturbances are among the commonly reported problems associated with PMS. Mandala coloring, as an accessible and easy-to-use art-based activity that does not require specific skills, may promote psychological relaxation, reduce anxiety, and improve sleep quality. However, the effects of mandala coloring on sleep quality and anxiety among women experiencing PMS have not been directly investigated. Therefore, this clinical trial aims to evaluate the effect of a mandala coloring intervention on sleep quality and anxiety levels in women with PMS. The findings may provide evidence for the use of mandala coloring as a simple, accessible, and non-pharmacological approach to support the management of PMS-related symptoms."},
{"id":"NCT07834489","registry":"ClinicalTrials.gov","slug":"anti-inflammatory-diet-and-physical-activity-for-nct07834489","match":"direct","title":"Anti-Inflammatory Diet and Physical Activity for Reproductive Health in Adolescent Girls","official_title":"A School-Based Anti-Inflammatory Dietary Intervention With or Without a Physical Activity Programme to Support Reproductive Health in Adolescent Girls","acronym":"4fertil","status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Reproductive Health"],"keywords":["Anti-Inflammatory Diet","Mediterranean Diet","Physical Activity","Diet Quality","Menstrual Health","Premenstrual Symptoms","Menstrual Pain","KIDMED","Salivary Biomarkers","Oral Microbiome"],"interventions":[{"type":"BEHAVIORAL","name":"Anti-Inflammatory Dietary Intervention"},{"type":"BEHAVIORAL","name":"Physical Activity and Training Programme"}],"sponsor":"Poznan University of Physical Education","sponsor_class":"OTHER","collaborators":["Ministry of Science and Higher Education, Poland"],"countries":["Poland"],"enrollment":100,"enrollment_type":"ESTIMATED","start_date":"2026-10-20","completion_date":"2027-06-30","first_posted":"2026-09-22","last_update":"2026-09-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07834489","reference_pmids":[],"brief_summary":"This study will evaluate whether a 16-week anti-inflammatory dietary intervention, delivered alone or together with a physical activity programme, can improve diet quality and support reproductive health in girls aged 14-19 years. Approximately 100 participants will be recruited from two secondary schools in Poland. Participants at both schools will receive education and practical guidance on an anti-inflammatory diet based on Mediterranean dietary principles. Participants at one school will additionally take part in a supervised physical activity programme conducted twice weekly. The primary outcome will be the change in diet quality assessed using the KIDMED index. Additional assessments will examine menstrual health, premenstrual symptoms, menstrual pain, physical activity, body composition, anthropometric measures, selected salivary biomarkers, and the oral microbiome. Assessments will be conducted before and after the intervention."},
{"id":"NCT07814807","registry":"ClinicalTrials.gov","slug":"the-effects-of-manual-lymphatic-drainage-and-self-manual-nct07814807","match":"direct","title":"The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage","official_title":"Comparison of the Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage on the Autonomic Nervous System and Premenstrual Symptoms in Women With Premenstrual Syndrome: A Sham-Controlled Study","acronym":"MLD-SMLD","status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Manual Lymphatic Drainage","Self-Manual Lymphatic Drainage","Heart Rate Variability","Autonomic Nervous System","Edema","Pain"],"interventions":[{"type":"OTHER","name":"Manual Lymphatic Drainage (MLD)"},{"type":"OTHER","name":"Self-Manual Lymphatic Drainage (Self-MLD)"},{"type":"OTHER","name":"Sham Manual Lymphatic Drainage (Sham MLD)"}],"sponsor":"Izmir Democracy University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2026-10-05","completion_date":"2027-07-05","first_posted":"2026-09-11","last_update":"2026-09-11","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07814807","reference_pmids":[],"brief_summary":"This randomized controlled study aims to compare the effects of manual lymphatic drainage (MLD), self-manual lymphatic drainage (self-MLD), and sham MLD on autonomic nervous system activity and premenstrual symptoms in women with premenstrual syndrome (PMS). A total of 60 women with PMS will be randomly assigned to three groups: MLD, self-MLD, or sham MLD. The intervention will be conducted during the luteal phase of the menstrual cycle for 2 weeks, with three sessions per week, for a total of six sessions. Outcomes will include premenstrual symptoms, heart rate and heart rate variability, blood pressure, pain, edema, quality of life, fatigue, depression, anxiety, and stress. Assessments will be performed at predetermined time points before, during, and after the intervention to compare the acute and overall effects of the three approaches."},
{"id":"NCT07803497","registry":"ClinicalTrials.gov","slug":"the-effect-of-a-reflexology-program-on-premenstrual-syndrome-nct07803497","match":"direct","title":"THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT","official_title":"THE EFFECT OF A REFLEXOLOGY PROGRAM APPLİED TO UNİVERSİTY STUDENTS ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":["University students, reflexology, premenstrual syndrome, quality of life, general comfort."],"interventions":[{"type":"BEHAVIORAL","name":"Foot Reflexology Massage"}],"sponsor":"Dokuz Eylul University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":120,"enrollment_type":"ESTIMATED","start_date":"2026-10-01","completion_date":"2027-05-01","first_posted":"2026-09-03","last_update":"2026-09-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07803497","reference_pmids":[],"brief_summary":"This study aims to evaluate the effect of foot reflexology on premenstrual syndrome symptoms, quality of life, and comfort levels among university students with premenstrual syndrome. The study will be conducted as a randomized controlled experimental study. Participants will be assigned to intervention and control groups. The intervention group will receive 30-minute foot reflexology sessions four times a month for three months, while the control group will receive no intervention. The outcomes will be assessed before and after the intervention."},
{"id":"NCT07688720","registry":"ClinicalTrials.gov","slug":"transcutaneous-auricular-neurostimulation-tan-for-nct07688720","match":"direct","title":"Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause","official_title":"Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Perimenopause","PMDD"],"keywords":["Premenstrual Symptoms","Menopause","Women's health","Perimenopause","Premenstrual Dysphoric Disorder"],"interventions":[{"type":"DEVICE","name":"transcutaneous auricular neurostimulation (tAN)"}],"sponsor":"Texas Christian University","sponsor_class":"OTHER","collaborators":["Spark Biomedical, Inc."],"countries":["United States"],"enrollment":20,"enrollment_type":"ESTIMATED","start_date":"2026-10","completion_date":"2027-03","first_posted":"2026-07-07","last_update":"2026-09-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07688720","reference_pmids":[],"brief_summary":"Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention, and following the intervention."},
{"id":"NCT07756203","registry":"ClinicalTrials.gov","slug":"pmt-versus-iastm-in-subacromial-impingement-syndrome-nct07756203","match":"direct","title":"PMT Versus IASTM in Subacromial Impingement Syndrome","official_title":"Comparative Effects of Percussion Massage Therapy and Instrument-Assisted Soft Tissue Mobilization as Adjuncts to Conventional Physiotherapy in Subacromial Impingement Syndrome: A Randomized Controlled Trial","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Impingement Syndrome","Impingement Shoulder","Shoulder Pain"],"keywords":["Subacromial Impingement Syndrome","Shoulder Pain","Instrument-Assisted Soft Tissue Mobilization (IASTM)","Percussion Massage Therapy","Physiotherapy"],"interventions":[{"type":"DEVICE","name":"Percussion massage therapy device"},{"type":"DEVICE","name":"Instrument-assisted soft tissue mobilization device"},{"type":"OTHER","name":"Conventional Physiotherapy"}],"sponsor":"Emre DANSUK","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":42,"enrollment_type":"ESTIMATED","start_date":"2026-08-10","completion_date":"2026-10-20","first_posted":"2026-08-10","last_update":"2026-08-25","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07756203","reference_pmids":[],"brief_summary":"This assessor-blinded, three-arm, parallel-group randomized controlled trial will investigate the additional effects of percussion massage therapy and instrument-assisted soft tissue mobilization in individuals with subacromial impingement syndrome. Forty-eight participants aged 40-60 years with clinically and magnetic resonance imaging-confirmed subacromial impingement syndrome will be randomly allocated in a 1:1:1 ratio to conventional physiotherapy, percussion massage therapy plus conventional physiotherapy, or instrument-assisted soft tissue mobilization plus conventional physiotherapy. All groups received a standardized four-week conventional physiotherapy programme. Participants in the percussion massage therapy and instrument-assisted soft tissue mobilization groups additionally received their respective interventions three times per week for four weeks. Outcomes were evaluated at baseline and immediately after the four-week intervention. The primary outcome was shoulder joint position sense during flexion and abduction. Secondary outcomes were shoulder range of motion, resting and activity-related pain, upper-extremity disability, and rotator cuff-related quality of life."},
{"id":"NCT07754149","registry":"ClinicalTrials.gov","slug":"dose-response-effects-of-a-6-week-progressive-resistance-nct07754149","match":"direct","title":"Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls","official_title":"Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls","acronym":null,"status":"ACTIVE_NOT_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome, Resistance Training, Dose-Response, Adolescent Girls, Exercise Therapy, Quality of Life, Randomized Controlled Trial"],"interventions":[{"type":"OTHER","name":"Progressive Resistance Training"},{"type":"OTHER","name":"Low-Intensity Resistance Training"}],"sponsor":"Riphah International University","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":32,"enrollment_type":"ESTIMATED","start_date":"2026-08-10","completion_date":"2027-03","first_posted":"2026-08-10","last_update":"2026-09-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07754149","reference_pmids":[],"brief_summary":"This study examines the dose-response effects of a 6-week progressive resistance training program on premenstrual syndrome (PMS) in adolescent girls. PMS is a common condition that affects physical, psychological, and social well-being. While exercise is known to reduce symptoms, the optimal intensity of resistance training remains unclear. Using a randomized controlled trial design, participants are assigned to progressive or low-intensity training groups. PMS symptoms and quality of life are assessed over time. The study aims to determine whether higher exercise intensity leads to greater symptom reduction and improved overall well-being."},
{"id":"NCT07684495","registry":"ClinicalTrials.gov","slug":"aerobic-exercises-versus-sub-occipital-myofascial-release-on-nct07684495","match":"direct","title":"Aerobic Exercises Versus Sub Occipital Myofascial Release on Memory Function in Females With Premenstrual Syndrome.","official_title":"Aerobic Exercises Versus Sub Occipital Myofascial Release on Memory Function in Females With Premenstrual Syndrome.","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Aerobic exercise"},{"type":"OTHER","name":"Sub occipital myofascial release"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":40,"enrollment_type":"ESTIMATED","start_date":"2026-07-03","completion_date":"2026-09-30","first_posted":"2026-07-06","last_update":"2026-07-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07684495","reference_pmids":[],"brief_summary":"This study will be conducted to investigate the effect of aerobic exercises versus sub occipital Myofascial release on memory functions in females with premenstrual syndrome."},
{"id":"NCT07684638","registry":"ClinicalTrials.gov","slug":"self-compassion-and-quality-of-life-in-nursing-students-with-nct07684638","match":"direct","title":"Self-Compassion and Quality of Life in Nursing Students With Premenstrual Syndrome","official_title":"The Mediating Role of Self-Compassion in the Association Between Premenstrual Symptom Severity and Premenstrual Syndrome-Specific Quality of Life Among Nursing Students With Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome","Quality of Life","Self Compassion"],"keywords":["Premenstrual Syndrome","Quality of life","Self Compassion"],"interventions":[],"sponsor":"Acibadem University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":164,"enrollment_type":"ACTUAL","start_date":"2026-06-26","completion_date":"2026-07-15","first_posted":"2026-07-06","last_update":"2026-07-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07684638","reference_pmids":["31181584","35113436","41680718"],"brief_summary":"Premenstrual syndrome (PMS) is one of the most common menstrual disorders among women of reproductive age and is characterized by recurrent physical, emotional, cognitive, and behavioral symptoms during the late luteal phase of the menstrual cycle. These symptoms may adversely affect academic performance, daily functioning, interpersonal relationships, and quality of life. Although previous studies have demonstrated that greater premenstrual symptom severity is associated with poorer quality of life, the psychological mechanisms underlying this relationship remain unclear. Self-compassion, defined as a compassionate and nonjudgmental attitude toward oneself during times of difficulty, has been identified as a protective psychological factor associated with better emotional well-being and adaptive coping. However, its mediating role in the relationship between premenstrual symptom severity and premenstrual syndrome-specific quality of life has not been adequately investigated. This cross-sectional study aims to examine the association between premenstrual symptom severity and premenstrual syndrome-specific quality of life and to investigate the mediating role of self-compassion among nursing students who meet the study criteria for PMS (Premenstrual Syndrome Scale score ≥110)."},
{"id":"NCT07679074","registry":"ClinicalTrials.gov","slug":"crest-samphire-guided-care-program-on-wellbeing-work-nct07679074","match":"direct","title":"CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life","official_title":"A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions","acronym":"CREST","status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome","Premenstrual Dysphoric Disorder","Dysmenorrhea","Endometriosis","Perimenopause","Menopause","Pelvic Pain"],"keywords":["tDCS","neuromodulation","hormonal health","menstrual symptoms","perimenopause","menopause","PMDD","PMS","work productivity","brain fog","mood","cognitive function","digital health","decentralized clinical trial","guided care"],"interventions":[{"type":"DEVICE","name":"Lutea Transcranial Direct Current Stimulation (tDCS) Device"},{"type":"BEHAVIORAL","name":"Samphire Guided Care Program"}],"sponsor":"Samphire Group, Inc.","sponsor_class":"INDUSTRY","collaborators":[],"countries":["United States"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2026-06-01","completion_date":"2027-03-01","first_posted":"2026-07-01","last_update":"2026-07-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07679074","reference_pmids":[],"brief_summary":"This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program * a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause."},
{"id":"NCT07554950","registry":"ClinicalTrials.gov","slug":"evaluating-the-impact-of-psychoeducation-and-sleep-informed-nct07554950","match":"direct","title":"Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder","official_title":"Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder","acronym":"PMDD","status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Sleep Disturbances","PMDD","PMS"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Psychoeducation and Sleep-Informed Workshop"}],"sponsor":"St. Joseph's Healthcare Hamilton","sponsor_class":"OTHER","collaborators":["McMaster University"],"countries":["Canada"],"enrollment":72,"enrollment_type":"ESTIMATED","start_date":"2026-06","completion_date":"2027-12","first_posted":"2026-04-28","last_update":"2026-04-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07554950","reference_pmids":[],"brief_summary":"Premenstrual Dysphoric Disorder (PMDD) is a cyclical mood disorder characterized by emotional, cognitive, physical, and sleep-related symptoms that occur in the days leading up to menstruation and improve shortly after menstruation begins. Although medications are commonly used to treat PMDD, many individuals experience side effects, do not benefit from medication, or prefer non-medication-based approaches. Sleep difficulties are very common in individuals with PMDD and may contribute to mood symptoms, emotional regulation difficulties, and functional impairment. Psychological interventions that focus on sleep, such as sleep psychoeducation and cognitive-behavioural strategies for insomnia, are effective in other mood and anxiety disorders but have not been well studied in PMDD. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored for individuals with PMDD or severe premenstrual symptoms. Information collected in this study may help inform future research and may improve care for individuals with PMDD."},
{"id":"NCT07801651","registry":"ClinicalTrials.gov","slug":"dual-task-postural-stability-in-women-with-premstrual-nct07801651","match":"direct","title":"Dual-Task Postural Stability in Women With Premstrual Syndrome: A Within-Subject Comparative Study","official_title":"Dual-Task Postural Stability in Women With Premstrual Syndrome: A Within-Subject Comparative Study","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"PMS Group"}],"sponsor":"Deraya University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2026-05-15","completion_date":"2026-07-20","first_posted":"2026-09-03","last_update":"2026-09-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07801651","reference_pmids":[],"brief_summary":"This within-subject repeated-measures study investigated dual-task postural stability in women with premenstrual syndrome (PMS) by comparing performance during the PMS and non-PMS phases of the menstrual cycle. The study also examined the relationship between PMS symptom severity and dual-task postural stability."},
{"id":"NCT07202650","registry":"ClinicalTrials.gov","slug":"the-effect-of-guided-imagery-on-premenstrual-syndrome-nct07202650","match":"direct","title":"THE EFFECT OF GUİDED IMAGERY ON PREMENSTRUAL SYNDROME","official_title":"EFFECT OF GUİDED IMAGERY ON PREMENSİVE SYNDROME İN UNİVERSİTY STUDENTS","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Guided Imagery","Premenstrual Syndrome","Nursing"],"keywords":["premenstrual syndrome","guided imagery","university students","quality of life"],"interventions":[{"type":"BEHAVIORAL","name":"guided imagery"}],"sponsor":"Baskent University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":48,"enrollment_type":"ESTIMATED","start_date":"2026-05-15","completion_date":"2026-12-15","first_posted":"2025-10-02","last_update":"2026-08-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07202650","reference_pmids":[],"brief_summary":"EFFECT OF GUIDED IMAGERY ON PREMENSTRUAL SYNDROME IN UNIVERSITY STUDENTS Premenstrual Syndrome (PMS) is a condition characterized by physical, behavioral, and emotional symptoms that appear at the end of the luteal phase, 7-10 days before menstruation, and resolve with the onset of menstruation. Symptoms include irritability, loss of control, anxiety, depression, sleep disturbances, decreased concentration, unexplained crying, fatigue, weakness, changes in appetite, edema, headaches, joint and muscle pain, breast tenderness, altered sexual activity, and social withdrawal. In young women, PMS can negatively affect self-confidence, social relationships, quality of life, and academic performance. PMS treatment aims to relieve both physical and psychological symptoms and may include dietary supplements and complementary-alternative therapies. Approaches such as reflexology, pilates, acupressure, music, exercise, and guided imagery have shown promising results in reducing premenstrual symptoms. Mind-body-based approaches in complementary therapies are known to support psychological well-being. Guided imagery, a form of mind-body communication, involves the flow of thoughts and the way the mind encodes, stores, and expresses sensory information. It is based on the understanding that the mind and body are interconnected and that mental processes can influence physical responses. Guided imagery has been shown to reduce stress, improve mood, enhance sleep quality, strengthen the immune system, reduce fatigue, and minimize nausea and vomiting. Although effective, research on the use of guided imagery to reduce PMS symptoms in university students is limited. This study aims to investigate the effect of guided imagery on premenstrual syndrome in this population."},
{"id":"NCT07686718","registry":"ClinicalTrials.gov","slug":"to-establish-whether-individuals-with-premenstrual-dysphoric-nct07686718","match":"direct","title":"To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.","official_title":"To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.","acronym":null,"status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Dysphoric Disorder ( PMDD)"],"keywords":["PMDD","premenstrual dysphoric disorder","oestrogen","progesterone","ratios"],"interventions":[],"sponsor":"Lancaster University","sponsor_class":"OTHER","collaborators":[],"countries":["United Kingdom"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2026-05-05","completion_date":"2027-08-01","first_posted":"2026-07-07","last_update":"2026-07-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07686718","reference_pmids":[],"brief_summary":"The aim of this project is to compare the ovarian hormone levels 7 days after ovulation and progesterone:oestradiol ratios between PMDD individuals and a control cohort (case control study)."},
{"id":"NCT06871345","registry":"ClinicalTrials.gov","slug":"perimenstrual-symptoms-and-emotional-dysregulation-in-autism-nct06871345","match":"direct","title":"Perimenstrual Symptoms and Emotional Dysregulation in Autism","official_title":"Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic Individuals: Ecological, Subjective, and Cognitive Approach","acronym":"MEDEA","status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"OTHER","conditions":["Autism Spectrum Disorder","Borderline Personality Disorder BPD","a Premenstrual Dysphoric Disorder (PMDD)"],"keywords":[],"interventions":[{"type":"OTHER","name":"Semi-structured interviews SCID"},{"type":"OTHER","name":"Self-report questionnaires"},{"type":"OTHER","name":"Momentary Ecological Assessment (EMA)"}],"sponsor":"University Hospital, Strasbourg, France","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":90,"enrollment_type":"ESTIMATED","start_date":"2026-05-01","completion_date":"2029-07-01","first_posted":"2025-03-11","last_update":"2026-05-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06871345","reference_pmids":[],"brief_summary":"Emotional dysregulation (ED) is defined by difficulties in modulating the experience and expression of emotions, which are characterized by particularly marked reactivity, intensity, and duration. To improve the understanding of ED, its consequences in autistic women, and to be able to offer them appropriate treatments, it seems crucial to investigate the links between ED, known adversities during childhood, and premenstrual dysphoric symptoms. This study aims to characterize the variability of ED throughout a menstrual cycle by measuring it in an ecological real-life context. The variability of ED will be compared to that of women with borderline personality disorder (BPD), women with premenstrual dysphoric disorder (PMDD), and women without a diagnosed disorder."},
{"id":"NCT07526623","registry":"ClinicalTrials.gov","slug":"combined-effect-of-benson-relaxation-technique-and-jacobson-nct07526623","match":"direct","title":"Combined Effect of Benson Relaxation Technique and Jacobson Progressive Muscle Relaxation Exercises on Premenstrual Syndrome","official_title":"Combined Effect of Benson Relaxation and Jacobson Progressive Muscle Relaxation Techniques on Premenstrual Syndrome","acronym":null,"status":"ACTIVE_NOT_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":[],"interventions":[{"type":"OTHER","name":"Jacobson progressive muscle relaxation technique"},{"type":"OTHER","name":"Benson relaxation technique"},{"type":"OTHER","name":"combine Jacobson progressive muscle relaxation and Benson relaxation technique"}],"sponsor":"University of Health Sciences Lahore","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":56,"enrollment_type":"ACTUAL","start_date":"2026-04-07","completion_date":"2026-06-21","first_posted":"2026-04-13","last_update":"2026-04-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07526623","reference_pmids":[],"brief_summary":"Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle .Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. The aim of this study is to determine the combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques on Premenstrual syndrome. Three-arm parallel Randomized control trial (study design) in which three groups will be formed. A sample size of 56 female students will be selected from University of Health Sciences, Lahore using the purposive sampling technique and will be equally and randomly allocated to three groups using computer generated random number by Excel software. Jacobson PMR technique will be applied on group A and Benson Relaxation Technique on group B and both Benson relaxation and Jacobson progressive muscle relaxation techniques will be applied on group C for two months three times a week. Symptoms will be assessed before and at 8th week (at the end of treatment) by using the Premenstrual Syndrome Scale. There will be assessor blinding while data collecting in order to reduce biasness. The potential significance of combined effect of Benson relaxation technique and Jacobson progressive muscle relaxation is to reduce the symptoms of PMS, improving the quality of life, provide the non-pharmacological approach, improve daily functioning, provide the empowerment to women, enhance relationship, cost - effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving symptoms and provide mental and physical relaxation which will help women in enhancing self-control, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities."},
{"id":"NCT07128407","registry":"ClinicalTrials.gov","slug":"pmt-based-radiation-safety-training-for-nurses-randomized-nct07128407","match":"direct","title":"PMT-Based Radiation Safety Training for Nurses: Randomized Controlled Trial.","official_title":"The Effect of Radiation Protection Training Based on Protection Motivation Theory on Nurses' Knowledge, Awareness, Motivation and Safety Behaviors: A Randomized Controlled Trial.","acronym":null,"status":"ACTIVE_NOT_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Occupational Radiation Exposure in Operating Room Nurses"],"keywords":["Radiation Protection","Occupational Safety","Nursing Safety Behavior","Occupational Radiation Exposure","Protection Motivation Theory","Randomized Controlled Trial"],"interventions":[{"type":"BEHAVIORAL","name":"Protection Motivation Theory-Based Radiation Protection Training"}],"sponsor":"Necmettin Erbakan University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":54,"enrollment_type":"ESTIMATED","start_date":"2026-04-01","completion_date":"2026-12-01","first_posted":"2025-08-19","last_update":"2026-04-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07128407","reference_pmids":[],"brief_summary":"This randomized controlled trial aims to evaluate the effect of a Protection Motivation Theory (PMT)-based radiation protection training program on nurses' knowledge, awareness, motivation, and safety behaviors. The study includes 54 operating room nurses randomly assigned to experimental (n=27) and control (n=27) groups. The intervention targets both threat appraisal (perceived severity and vulnerability) and coping appraisal (response efficacy, self-efficacy, and response cost) processes. It is hypothesized that PMT-based training will improve nurses' radiation protection knowledge, increase awareness, strengthen motivation, and enhance safety behaviors. The findings are expected to contribute to nursing curricula, institutional radiation safety policies, and the development of a safety culture in healthcare settings."},
{"id":"NCT07575698","registry":"ClinicalTrials.gov","slug":"the-effect-of-seed-cycling-based-nutritional-intervention-on-nct07575698","match":"direct","title":"The Effect of Seed Cycling-Based Nutritional Intervention on Premenstrual Symptoms","official_title":"Evaluation of the Effect of Seed Cycling on Premenstrual Symptoms in Healthy Adults","acronym":null,"status":"ACTIVE_NOT_RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Seed Cycling","Nutrition Habits","Premenstrual Syndrome-PMS"],"keywords":["seed consumption","premenstrual syndrome","follicular phase","luteal phase"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Seed consumption"}],"sponsor":"TC Erciyes University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":48,"enrollment_type":"ESTIMATED","start_date":"2026-03-20","completion_date":"2027-03-20","first_posted":"2026-05-08","last_update":"2026-05-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07575698","reference_pmids":[],"brief_summary":"This study aims to investigate the effects of the seed-cycling intervention on premenstrual symptoms and nutritional status. At the beginning of the study, written informed consent will be obtained from all individuals who agree to participate. During the month prior to the intervention, participants' menstrual cycles will be monitored to determine their menstrual phases. In this period, dietary intake records and menstrual symptoms will be documented, and the estimated ovulation date will be determined based on reported symptoms. After identifying the participants' follicular phase (approximately days 1-14) and luteal phase (approximately days 15-28), the intervention will be implemented for three consecutive months. Participants will be instructed to consume flaxseed and pumpkin seeds daily during the follicular phase, and sesame seeds and sunflower seeds daily during the luteal phase. The oilseeds to be consumed will be provided to the participants at the beginning of each month in vacuum-sealed single-use packages."},
{"id":"NCT07441096","registry":"ClinicalTrials.gov","slug":"efficacy-and-safety-of-shatavari-root-extract-for-nct07441096","match":"direct","title":"Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women","official_title":"Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Women Health"],"keywords":["PMS","Shatavari","Asparagus racemosus"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Shatavari Root Extract"},{"type":"OTHER","name":"Placebo Capsule"}],"sponsor":"SF Research Institute, Inc.","sponsor_class":"NETWORK","collaborators":["Ixoreal Biomed Private Limited"],"countries":["United States"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2026-03-20","completion_date":"2026-07-08","first_posted":"2026-02-27","last_update":"2026-03-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07441096","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life. This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study."},
{"id":"NCT07864285","registry":"ClinicalTrials.gov","slug":"occupational-physicians-facing-premenstrual-dysphoric-nct07864285","match":"direct","title":"Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health","official_title":"Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health","acronym":"TDPM","status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Dysphoric Disorder (PMDD)"],"keywords":["PMDD","Occupational health","Menstrual disorders"],"interventions":[],"sponsor":"University Hospital, Strasbourg, France","sponsor_class":"OTHER","collaborators":[],"countries":["France"],"enrollment":15,"enrollment_type":"ESTIMATED","start_date":"2026-03-09","completion_date":"2027-03-09","first_posted":"2026-10-07","last_update":"2026-10-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07864285","reference_pmids":[],"brief_summary":"This study aims to assess the knowledge, perceptions and practices of occupational physicians regarding premenstrual dysphoric disorder (PMDD), a condition with significant occupational impact that remains insufficiently explored in occupational health."},
{"id":"NCT07599436","registry":"ClinicalTrials.gov","slug":"laughter-yoga-and-sleep-hygiene-training-for-college-nct07599436","match":"direct","title":"Laughter Yoga and Sleep Hygiene Training for College Students With Premenstrual Syndrome","official_title":"The Effect of Laughter Yoga and Sleep Hygiene Training on Premenstrual Syndrome Levels, Perceived Stress Levels, and Sleep Quality Among University Students","acronym":"LYSHPMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Laughter Yoga","Premenstrual Syndrome-PMS","Stress","Sleep Quality"],"keywords":["Laughter Yoga","Premenstrual Syndrome","Stress","Nursing Students","Non-pharmacological method","Sleep Hygiene"],"interventions":[{"type":"BEHAVIORAL","name":"Supportive Care"}],"sponsor":"Gazi University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":45,"enrollment_type":"ACTUAL","start_date":"2026-03-01","completion_date":"2026-05-01","first_posted":"2026-05-20","last_update":"2026-05-20","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07599436","reference_pmids":[],"brief_summary":"This study aims to evaluate the effects of laughter yoga and sleep hygiene training on premenstrual syndrome (PMS) symptoms, perceived stress levels, and sleep quality among nursing students.Premenstrual syndrome is a common health issue characterized by physical symptoms as well as emotional fluctuations, anxiety, depressive mood, and behavioral changes, which can negatively impact quality of life. Additionally, it is known that stress is a significant risk factor that exacerbates PMS symptoms, and that healthy lifestyle behaviors may be effective in alleviating these symptoms. In this context, it has been reported that yoga and similar relaxation-based practices support mental well-being by reducing stress levels.The intervention consists of laughter yoga and sleep hygiene education, implemented as non-pharmacological methods over a 4-week period.Participants were assessed at baseline, immediately following the intervention, and during the 1-month follow-up period. The primary objective is to observe improved sleep quality alongside reductions in PMS symptoms and stress levels in participants as a result of the intervention. The findings are expected to contribute to the effectiveness of non-pharmacological, low-cost, and feasible approaches in managing PMS symptoms, as well as addressing stress and sleep quality."},
{"id":"NCT07409337","registry":"ClinicalTrials.gov","slug":"self-acupressure-for-primary-dysmenorrhea-and-premenstrual-nct07409337","match":"direct","title":"Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms","official_title":"Effects of Self-Acupressure on Primary Dysmenorrhea and Premenstrual Symptoms in Women Aged 18-30: A Randomized, Sham-Controlled, 6-Month Trial","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Primary Dysmenorrhea","Premenstrual Syndrome","Menstrual Pain"],"keywords":["Self-acupressure","Dysmenorrhea","Premenstrual symptoms","Menstrual pain","Non-pharmacological treatment","Sham-controlled trial"],"interventions":[{"type":"OTHER","name":"Self-Acupressure"},{"type":"OTHER","name":"Sham Self-Acupressure"}],"sponsor":"Nigde Omer Halisdemir University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":120,"enrollment_type":"ESTIMATED","start_date":"2026-02-15","completion_date":"2026-12-15","first_posted":"2026-02-13","last_update":"2026-08-24","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07409337","reference_pmids":[],"brief_summary":"This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be applied during the premenstrual and menstrual periods over approximately six months. The primary outcome is the change in menstrual pain severity, and secondary outcomes include changes in premenstrual symptom severity, analgesic use, and menstruation-related activity limitation."},
{"id":"NCT07399847","registry":"ClinicalTrials.gov","slug":"investigating-the-effects-of-time-of-day-and-menstrual-cycle-nct07399847","match":"related","title":"Investigating the Effects of Time-of-day and Menstrual Cycle Phase (Low and High Progesterone) on Female's Cognitive and Strength Performance","official_title":"Effects of Time-of-day and Menstrual Cycle Phase (Low and High Progesterone) on Female's Cognitive and Strength Performance","acronym":null,"status":"NOT_YET_RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Circadian Rhythm","Menstrual Cycle Phase","Female Athletes","Executive Function (Cognition)","Eumenorrhea","Strength"],"keywords":[],"interventions":[],"sponsor":"Lancaster University","sponsor_class":"OTHER","collaborators":["Liverpool John Moores University"],"countries":[],"enrollment":30,"enrollment_type":"ESTIMATED","start_date":"2026-02","completion_date":"2026-09","first_posted":"2026-02-10","last_update":"2026-02-10","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07399847","reference_pmids":[],"brief_summary":"This study is designed to determine whether time-of-day and menstrual cycle phase influence athletic performance and is expected to contribute valuable insight into how both time-of-day, and hormonal factors can influence performance and expand existing research. This study aims to support more inclusive, effective and personalised approaches to training and competition schedules for female athletes. The study will involve two testing days that require a participant to complete a compilation of tests at 07:00, 12:00 and 18:00 hours. The testing days will be arranged for when a participant is in phase 1 (lowest levels of progesterone in the menstrual cycle) and phase 4 (highest level of progesterone in the menstrual cycle). The tests will examine a participant's executive function and physical strength. This study will aim to recruit thirty 18-30-year-old females from Lancaster University who identify with a sport that they train \\~3 times a week for with a purpose to compete. The females recruited must have a regular menstrual cycle and no history of sleep disorders. Aim: To investigate the effects of time-of-day and menstrual cycle phase (low and high progesterone levels) on executive function and strength in females. Objectives: 1. To determine the effects of time-of-day on executive function and strength tests. 2. To determine the effects of menstrual cycle phase on executive function and strength tests. 3. To examine if there is an interaction between time-of-day and menstrual cycle phase on executive function and strength tests."},
{"id":"NCT07376759","registry":"ClinicalTrials.gov","slug":"primary-dysmenorrhea-and-comfort-theory-nct07376759","match":"direct","title":"Primary Dysmenorrhea and Comfort Theory","official_title":"Effects of Comfort Theory-Based Education on Dysmenorrhea, Menstrual Symptoms, Premenstrual Syndrome and General Well-Being Levels in University Students With Primary Dysmenorrhea","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Primary Dysmenorrhea"],"keywords":["primary dysmenorrhea","comfort theory","menstrual symptoms","premenstrual syndrome","general wellbeing","nursing"],"interventions":[{"type":"OTHER","name":"Comfort Theory-Based Education"}],"sponsor":"Ordu University","sponsor_class":"OTHER","collaborators":["Ordu University Scientific Research Projects Coordination Department"],"countries":[],"enrollment":80,"enrollment_type":"ESTIMATED","start_date":"2026-02","completion_date":"2026-06","first_posted":"2026-01-29","last_update":"2026-01-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07376759","reference_pmids":[],"brief_summary":"Dysmenorrhea is defined as lower abdominal pain experienced during menstruation. It is divided into two types: primary dysmenorrhea and secondary dysmenorrhea. In young women, the majority of dysmenorrhea cases are primary dysmenorrhea. Primary dysmenorrhea has a physical, psychological, and social impact on young women. Pharmacological and non-pharmacological methods are used to treat primary dysmenorrhea. Education is important in increasing the effectiveness of primary dysmenorrhea treatment. An effective education process takes place in accordance with nursing theories and models. There are a limited number of studies on the effect of comfort theory-based education in the management of primary dysmenorrhea. In this research, planned as a randomized controlled trial, the intervention group will receive comfort theory-based education, while the control group will receive no intervention. This study aims to contribute to the literature by investigating the effect of comfort theory-based education on dysmenorrhea, menstrual symptoms, premenstrual syndrome, and general well-being in university students with primary dysmenorrhea."},
{"id":"NCT07699224","registry":"ClinicalTrials.gov","slug":"menstrual-cycle-symptoms-and-female-health-nct07699224","match":"direct","title":"Menstrual Cycle Symptoms and Female Health","official_title":"Prevalence of Subclinical Ovulatory Disturbances and Symptoms During the Menstrual Cycle and Their Relationship With Physical and Mental Health in Spanish Women of Reproductive Age (Prevalencia de Alteraciones Ovulatorias subclínicas y síntomas Durante el CICLO Menstrual y su relación Con la Salud física y Mental en Mujeres españolas en Edad Reproductiva).","acronym":"CICLOS","status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Menstrual Cycle","Menstrual Distress (Dysmenorrhea)","Premenstrual Syndrome","Abnormal Uterine Bleeding (AUB)","Ovulation Disorder","Perceived Health Status"],"keywords":[],"interventions":[{"type":"OTHER","name":"Prevalence"}],"sponsor":"Universidad Rey Juan Carlos","sponsor_class":"OTHER","collaborators":[],"countries":["Spain"],"enrollment":400,"enrollment_type":"ESTIMATED","start_date":"2026-01-21","completion_date":"2026-12","first_posted":"2026-07-13","last_update":"2026-07-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07699224","reference_pmids":[],"brief_summary":"The complexity inherent to the hormonal fluctuations associated with the female menstrual cycle (MC) has contributed, from a methodological perspective in research, to the neglect of women's physiological characteristics and to the silencing and normalization of symptoms linked to different life stages and hormonal environments. The scarce and outdated available data suggest high percentages of women experiencing perimenstrual symptoms, such as premenstrual syndrome or menstrual pain, as well as intermenstrual discomfort. These symptoms not only significantly impair daily activities but, due to their normalization, often lead to the underdiagnosis of other gynecological conditions. Subclinical ovulatory disturbances-characterized by the suppression of ovarian hormones as an adaptive defense mechanism against various environmental stressors-are also frequently underdiagnosed. These disturbances typically do not affect MC length, making them difficult to detect, and although the process is reversible, it may initiate irreversible consequences for certain tissues, such as bone mass loss. However, neither women nor their educational, occupational, or healthcare environments appear to have the resources and/or knowledge required to adequately address these issues. All of this may compromise women's rights to adequate sexual and reproductive health and to a dignified quality of life, as recognized under the second line of Axis 4, \"Effective Rights for All Women,\" of the Strategic Plan for Effective Equality between Women and Men 2022-2025. Therefore, the aims of this multicenter project-carried out by a multidisciplinary research team from seven Spanish universities and three international institutions-are to describe the prevalence of symptoms and alterations related to the MC in women of reproductive age and to identify their associations with physical and mental health. To accomplish this, an observational study will be conducted in a large sample of women of reproductive age, including multiple symptom and perceived-health questionnaires and ovulation monitoring. In addition, in a subsample of participants, bone mineral density will be assessed, blood levels of sex hormones will be monitored, and an innovative analysis of health biomarkers (glycemic and lipid profile, and inflammation) from menstrual blood will be included. This will be complemented by a qualitative study of experiences related to MC-associated symptoms and alterations, using in-depth interviews and thematic content analysis. The findings of this project are expected to support various dissemination and educational actions, justify the design of more inclusive educational and healthcare policies, and enhance the understanding of women's needs, ultimately contributing to improved symptom management and quality of life."},
{"id":"NCT07303933","registry":"ClinicalTrials.gov","slug":"female-concussion-head-cooling-nct07303933","match":"related","title":"Female Concussion Head Cooling","official_title":"The Association Between Head Cooling and Cognition, Neuroinflammatory Cytokines, Menstrual Cycle, Sleep Patterns, Mental Health and Concussions","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Concussion (Diagnosis)","Concussion Post Syndrome","Concussion, Mild"],"keywords":["Brain cooling","Concussion","Neuroinflammation","Mental Health","Cognition","Menstrual cycle","Female"],"interventions":[{"type":"DEVICE","name":"Brain Cooling"}],"sponsor":"Penn State University","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":32,"enrollment_type":"ESTIMATED","start_date":"2026-01-15","completion_date":"2027-01-01","first_posted":"2025-12-26","last_update":"2025-12-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07303933","reference_pmids":["12970518","28038481","28712093","30123177","34009790","37678507"],"brief_summary":"This research is being done to examine the benefits of a 28 day head cooling intervention on cognition, inflammation of the brain, sleep quality, menstrual symptom interaction, and mood in acutely concussed females. Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for decreasing timeline of full concussion recovery, particularly in females during periods of confounding neuropsychological menstrual symptoms, remains unexplored."},
{"id":"NCT07789626","registry":"ClinicalTrials.gov","slug":"effect-of-health-belief-model-based-peer-education-on-nct07789626","match":"direct","title":"Effect of Health Belief Model-Based Peer Education on Premenstrual Syndrome","official_title":"The Effect of Health Belief Model-Based Peer Education on University Students' Coping With Premenstrual Syndrome: A Randomized Controlled Trial","acronym":"HBM-PEPS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome-PMS"],"keywords":["peer education","health belief model","Premenstrual Syndrome (PMS)","women's health"],"interventions":[{"type":"BEHAVIORAL","name":"Peer Education Group"}],"sponsor":"Koç University","sponsor_class":"OTHER","collaborators":["Atlas University"],"countries":["Turkey (Türkiye)"],"enrollment":50,"enrollment_type":"ACTUAL","start_date":"2026-01-12","completion_date":"2026-06-28","first_posted":"2026-08-27","last_update":"2026-08-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07789626","reference_pmids":[],"brief_summary":"This study aims to examine the effect of peer education based on the Health Belief Model (HBM) on university students' coping skills with premenstrual syndrome (PMS). PMS is a common health problem that lowers women's quality of life and negatively affects their social and academic performance. The study will be conducted with 56 female students studying at Istanbul Atlas University, utilizing a randomized controlled design. Following the administration of a pre-test, participants diagnosed with PMS will be randomly assigned to either the intervention or control groups. The intervention group will be taught strategies for coping with PMS symptoms through peer education, while the control group will only receive an educational brochure. The training sessions will be structured framework of the Health Belief Model and will cover topics such as the definition, causes, and risk factors of PMS, as well as healthy lifestyle habits (nutrition, exercise, stress management). Data will be collected using pre-test and post-test methods, and changes in PMS symptoms will be analyzed using SPSS software. The study is expected to increase students' awareness of PMS and strengthen their ability to cope with symptoms as a result of peer education. The study duration is planned for 12 months and is projected to be conducted between 2025 and 2026. The intervention group will receive peer education based on the Health Belief Model framework covering topics such as the causes, symptoms, and risk factors of PMS. The training will be delivered in a classroom setting as two sessions conducted biweekly. Lecture, group discussions, and audiovisual materials will be used as educational methods. Personal Information Form and the Premenstrual Syndrome Scale will be used as data collection tools. The scale will be first administered in the pre-test to evaluate the severity of the participants' PMS symptoms. Following random assignment, the scale will be administered three times prior to three menstrual cycles for both intervention and control groups. The obtained data will be analyzed using SPSS software, and differences between groups will be evaluated using independent samples t-test and analysis of variance (ANOVA). The statistical significance level will be accepted as p\\<0.05. The findings to be obtained from this study are expected to demonstrate the potential of the peer education method to increase PMS awareness and strengthen coping skills with symptoms. The results of the research aim to contribute to the development of health education programs targeted toward university students."},
{"id":"NCT07074314","registry":"ClinicalTrials.gov","slug":"the-effect-of-laughter-yoga-and-premenstrual-symptoms-nct07074314","match":"direct","title":"The Effect of Laughter Yoga and Premenstrual Symptoms","official_title":"The Effect of Laughter Yoga on Quality of Life and Premenstrual Symptoms in Young People With Premenstrual Syndrome: A Randomized Controlled Experimental Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Quality of Life"],"keywords":["laughter yoga","premenstraul syndrome","qualifty of life"],"interventions":[{"type":"OTHER","name":"Laughter yoga"}],"sponsor":"Kırklareli University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":75,"enrollment_type":"ACTUAL","start_date":"2025-12-25","completion_date":"2025-12-30","first_posted":"2025-07-20","last_update":"2026-01-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07074314","reference_pmids":[],"brief_summary":"Premenstrual Syndrome (PMS) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. The emotional symptoms of PMS include depression, outbursts of anger, irritability, crying spells, anxiety, confusion, social withdrawal, poor concentration, insomnia, increased short sleep, and changes in sexual desire. Premenstrual symptoms negatively impact women's relationships with family, work, and friends, as well as their social activities. Furthermore, premenstrual symptoms negatively impact a woman's quality of life, making them an important issue to address early in a woman's life. Numerous treatment methods are used to reduce or eliminate PMS symptoms. Laughter yoga is one of the alternative medicine methods that has recently emerged and is used to maintain and improve health. No studies have examined the effectiveness of laughter yoga in reducing premenstrual syndrome. This study aims to determine the effects of laughter yoga on quality of life and premenstrual symptoms in young people experiencing premenstrual syndrome."},
{"id":"NCT07317232","registry":"ClinicalTrials.gov","slug":"ayahuasca-esketamine-and-premenstrual-symptoms-nct07317232","match":"direct","title":"Ayahuasca, Esketamine and Premenstrual Symptoms","official_title":"Effects of a Single Dose of Ayahuasca or Esketamine on the Menstrual Cycle and Premenstrual Symptoms: a Randomized, Double-Blind Study","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Healthy Women Volunteers"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ayahuasca"},{"type":"DRUG","name":"Esketamine"}],"sponsor":"University of Sao Paulo","sponsor_class":"OTHER","collaborators":[],"countries":["Brazil"],"enrollment":20,"enrollment_type":"ESTIMATED","start_date":"2025-12-20","completion_date":"2026-07","first_posted":"2026-01-05","last_update":"2026-01-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07317232","reference_pmids":[],"brief_summary":"Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms."},
{"id":"NCT07646769","registry":"ClinicalTrials.gov","slug":"health-belief-model-based-podcast-education-for-premenstrual-nct07646769","match":"direct","title":"Health Belief Model-Based Podcast Education for Premenstrual Symptoms in University Students","official_title":"Effect of a Health Belief Model-Based Podcast Education Program on Premenstrual Symptom Severity and PMS-Specific Quality of Life in University Students: A Single-Group Pretest-Posttest Quasi-Experimental Study","acronym":"HBM-PMS-POD","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","Premenstrual symptoms","podcast","health belief model","Digital health education","University students","Young women","Quality of life"],"interventions":[{"type":"BEHAVIORAL","name":"Health Belief Model-Based Podcast Education Program"}],"sponsor":"Medipol University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":120,"enrollment_type":"ACTUAL","start_date":"2025-12-15","completion_date":"2026-04-30","first_posted":"2026-06-15","last_update":"2026-06-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07646769","reference_pmids":[],"brief_summary":"Premenstrual syndrome is a common women's health condition characterized by physical, psychological, and behavioral symptoms that may negatively affect daily life, academic functioning, and quality of life among young women. This study evaluated the effect of a Health Belief Model-based podcast education program on premenstrual symptom severity and PMS-specific quality of life among young female university students living in Istanbul, Türkiye. This single-group pretest-posttest quasi-experimental study enrolled 120 participants. The intervention consisted of an eight-episode podcast education program delivered over four weeks, with two episodes per week. Premenstrual symptom severity and PMS-specific quality of life were assessed before and after the education program using validated scales."},
{"id":"NCT07052500","registry":"ClinicalTrials.gov","slug":"impact-of-seed-cycling-on-menstrual-regularity-dysmenorrhea-nct07052500","match":"direct","title":"Impact of Seed Cycling on Menstrual Regularity, Dysmenorrhea, and Premenstrual Symptoms","official_title":"Investigating the Impact of Seed Cycling on Menstrual Regularity, Dysmenorrhea, and Premenstrual Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"SUPPORTIVE_CARE","conditions":["Menstruation Disorders","Menstrual Cramps","Menstruation"],"keywords":["Seed Cycling","Menstrual Regularity","Dysmenorrhea","Premenstrual Symptoms"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Seed Cycling"}],"sponsor":"Loma Linda University","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":20,"enrollment_type":"ACTUAL","start_date":"2025-11-04","completion_date":"2026-05-07","first_posted":"2025-07-04","last_update":"2026-06-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07052500","reference_pmids":["25197571","31980022","35320895","37324929","37356456","38130524","8077314"],"brief_summary":"The purpose of this research is to investigate the impact of seed cycling on menstrual regularity, cramps, and pre-menstrual symptoms in women with an irregular menstrual cycle and/or dysmenorrhea. The research seeks to provide evidence-based insights into the potential benefits of seed cycling as a holistic approach to women's reproductive health. It is expected that your participation will last 3 months. Procedures and Activities. You will be provided with and asked to consume specific seeds daily. The seeds are to be consumed as follows: follicular phase (the period from the first day of menstruation (day 1) to ovulation (day 14) in a typical 28-day cycle): 1 tablespoon flax seeds and 1 tablespoon pumpkin seeds, and luteal phase (the period between ovulation and the start of the next period; typically days 15-28): 1 tablespoon sunflower seeds and 1 tablespoon sesame seeds. Before the intervention and once monthly for a total of 3 cycles, you will be asked to complete an online menstrual health symptom questionnaire (MHSQ) and keep track of your menstrual cycle days on the built-in health tracking app on your electronic device. Risks. Some of the foreseeable risks or discomforts of your participation include the potential for mild gastrointestinal side effects, the potential for allergic reactions, and the possibility of no significant benefit. Benefits. Possible benefits include the potential for improved menstrual cycle regularity, the potential for a reduction in premenstrual syndrome (PMS) symptoms, and the potential for nutritional benefits. Societal benefits include additional knowledge on seed cycling to help manage menstrual regularity and PMS symptoms."},
{"id":"NCT07310485","registry":"ClinicalTrials.gov","slug":"examining-the-impact-of-phytoestrogens-supplementation-on-nct07310485","match":"direct","title":"Examining the Impact of Phytoestrogens Supplementation on the Gene Expression, and Premenstrual Syndrome in Primenopausal Women","official_title":"Examining the Impact of Phytoestrogens Supplementation on the Gene Expression and Premenstrual Syndrome in Perimenopausal Women Aged 40-55 in Jordan","acronym":null,"status":"ENROLLING_BY_INVITATION","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Apparently Healthy and Not Receiving Hormonal Therapy"],"keywords":["phytoestrogen, flaxseed, SDG lignans, perimenopause, PMS, gene expression"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"SDG lignans"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"sponsor":"University of Jordan","sponsor_class":"OTHER","collaborators":[],"countries":["Jordan"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2025-11-01","completion_date":"2026-08-31","first_posted":"2025-12-30","last_update":"2026-09-04","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07310485","reference_pmids":[],"brief_summary":"This randomized, double-blind, placebo-controlled clinical trial investigated the effects of flaxseed-derived phytoestrogen supplementation on selected gene-expression markers and premenstrual syndrome (PMS) severity among perimenopausal women aged 40-55 years in Jordan. Participants received either a flaxseed lignan extract providing 100 mg of lignans daily or a matched placebo for 12 weeks. Gene expression and PMS severity were assessed at baseline and at the end of the intervention to examine the potential effects of phytoestrogen supplementation on selected molecular markers and menstrual-related symptoms."},
{"id":"NCT07089654","registry":"ClinicalTrials.gov","slug":"evaluation-of-a-pmt-rehabilitation-nursing-plan-for-the-nct07089654","match":"direct","title":"Evaluation of a PMT Rehabilitation Nursing Plan for the Older Adults With MCI to Promote Cognitive Health","official_title":"Development and Evaluation of a Psychomotor Rehabilitation Nursing Plan for the Older Adults With Mild Cognitive Impairment to Promote Cognitive Health","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Mild Cognitive Impairment (MCI)"],"keywords":["PMT rehabilitation nursing plan"],"interventions":[{"type":"BEHAVIORAL","name":"A PMT rehabilitation nursing plan"},{"type":"BEHAVIORAL","name":"General rehabilitation nursing"}],"sponsor":"Jinzhou Medical University","sponsor_class":"OTHER","collaborators":["Universiti Sains Malaysia"],"countries":["China"],"enrollment":73,"enrollment_type":"ACTUAL","start_date":"2025-10-20","completion_date":"2026-01-30","first_posted":"2025-07-28","last_update":"2026-10-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07089654","reference_pmids":["28776280","32460123","32611388","33960574","37249513"],"brief_summary":"With the aging of the population, the number of older adults with mild cognitive impairment (MCI) has increased year by year, which has caused serious social and family burdens. At present, the existing drug treatment effect is limited. Studies show the application value of non-drug treatment in the older adults with mild cognitive impairment. Psychomotor Therapy (PMT) is now widely used in European countries and has formed an independent scientific system. Therefore, this topic pays attention to older adults with mild cognitive impairment, intending to promote cognitive stimulation, using PMT methods to build a rehabilitation nursing plan. Relying on older adults care institutions, older adults with mild cognitive impairment in a certain period were divided into a control group (CG) and an experimental group (EG). Older adults will be engaged in a 12-week PMT rehabilitation nursing plan involving relaxation and breathing exercises, face exercises, hand exercises, and mind exercises to promote cognitive health. SPSS 28.0 software was used to analyze data. The comparison of scores of various scales are based on paired t-test statistical methods. The P value \\<0.05 will be considered to indicate statistically significant with 95% confidence interval (CI). The rehabilitation effect of the two groups was evaluated according to cognitive assessments (Montreal Cognitive Assessment, MoCA), psychological assessment (Positive and Negative Syndrome Scale, PANSS), and emotional assessment (Hamilton Depression Rating Scale, HAMD-17; Hamilton Anxiety Rating Scale, HAMA-14) . The expected findings of this study may be useful for cognitive rehabilitation plans for the elderly in care institutions, rehabilitation hospitals, communities, and families."},
{"id":"NCT07139223","registry":"ClinicalTrials.gov","slug":"the-effect-of-laughter-yoga-on-premenstrual-syndrome-nct07139223","match":"direct","title":"The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women","official_title":"The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":["Premenstrual Syndrome","Laughter Yoga","Quality of Life"],"interventions":[{"type":"BEHAVIORAL","name":"laughter yoga"}],"sponsor":"Lokman Hekim University","sponsor_class":"OTHER_GOV","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":69,"enrollment_type":"ACTUAL","start_date":"2025-10-15","completion_date":"2025-12-15","first_posted":"2025-08-24","last_update":"2026-01-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07139223","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is a common condition among young women, characterized by physical, emotional, and behavioral symptoms that negatively affect quality of life. Laughter yoga, a non-pharmacological mind-body intervention combining breathing techniques, relaxation, and intentional laughter, has been shown to reduce stress, improve mood, and enhance well-being. This randomized controlled trial aims to evaluate the effect of laughter yoga on PMS symptoms and quality of life in young women."},
{"id":"NCT07189299","registry":"ClinicalTrials.gov","slug":"microdosing-lsd-in-women-with-premenstrual-disorders-nct07189299","match":"direct","title":"Microdosing LSD in Women With Premenstrual Disorders","official_title":"Role of the Serotonin 2A Receptor in Women With Premenstrual Disorders: a Randomized, Double-blind, Placebo-controlled Study (L4Her-Study)","acronym":"L4Her","status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["PMS","PMDD"],"keywords":["Hallucinogens","Serotonin Agents","LSD","Premenstrual disorders","Premenstrual syndrome","Psychotropic drugs","Microdose","Serotonin system","Psychedelics"],"interventions":[{"type":"DRUG","name":"LSD 10 μg every Day"},{"type":"DRUG","name":"LSD 10 μg every other day"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Friederike Holze","sponsor_class":"OTHER","collaborators":[],"countries":["Switzerland"],"enrollment":150,"enrollment_type":"ESTIMATED","start_date":"2025-10-01","completion_date":"2030-01-01","first_posted":"2025-09-23","last_update":"2025-09-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07189299","reference_pmids":[],"brief_summary":"The investigators aim to investigate the role of the serotonin 2A receptor in women with premenstrual disorders. This study uses a double-blind, randomized, controlled design with 3 arms: Intervention 1: 10 micg LSD for \\~10 days during the late luteal phase (for 3 cycles) Intervention 2: 10 micg LSD every other day for \\~10 days during the late luteal phase (for 3 cycles) Control intervention: Placebo for \\~10 days during the late luteal phase (for 3 cycles) Each participant will be treated in only one arm. The study employs a parallel design with three treatment arms and consists of a two-cycle observational phase followed by a three-cycle treatment phase."},
{"id":"NCT07155720","registry":"ClinicalTrials.gov","slug":"effects-of-kinesio-taping-on-premenstrual-syndrome-nct07155720","match":"direct","title":"Effects of Kinesio Taping on Premenstrual Syndrome","official_title":"Effects of Kinesio Taping on Premenstrual Syndrome, Happiness, and Quality of Life","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Over 18 Years Old"],"keywords":["kinesio-tape","kinesio-taping","nursing","happiness","quality of life"],"interventions":[{"type":"OTHER","name":"Intervention (Kinesio Taping) group"}],"sponsor":"Yağmur SÜRMELİ","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":42,"enrollment_type":"ESTIMATED","start_date":"2025-10-01","completion_date":"2026-03-01","first_posted":"2025-09-04","last_update":"2025-09-04","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07155720","reference_pmids":[],"brief_summary":"This randomized, single-blind study aimed to evaluate the effects of kinesio taping on PMS symptoms, happiness, and quality of life. The primary question(s) it aimed to answer were: Is there a significant difference in premenstrual symptoms, happiness, and quality of life between the kinesio taping intervention group and the sham taping placebo group?"},
{"id":"NCT07171814","registry":"ClinicalTrials.gov","slug":"cohort-study-of-honghua-xiaoyao-tablets-in-the-treatment-of-nct07171814","match":"direct","title":"Cohort Study of Honghua Xiaoyao Tablets in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework","official_title":"Cohort Study of Honghua Xiaoyao Tablet in the Treatment of Premenstrual Syndrome Based on Target Trial Emulation Framework","acronym":"TTE","status":"NOT_YET_RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["Honghua Xiaoyao tablet","Target trial emulation","The real world"],"interventions":[{"type":"DRUG","name":"Honghua Xiaoyao tablets"}],"sponsor":"Lianxin Wang","sponsor_class":"OTHER","collaborators":["Chaoyangmen Community Health Service Center of Dongcheng District in Beijing","Hepingli Community Health Service Center,Dongcheng District,Beijing"],"countries":[],"enrollment":266,"enrollment_type":"ESTIMATED","start_date":"2025-09-30","completion_date":"2027-09-30","first_posted":"2025-09-15","last_update":"2025-09-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07171814","reference_pmids":[],"brief_summary":"To evaluate the efficacy and safety of Honghua Xiaoyao tablets in the treatment of premenstrual syndrome, and the results were further analyzed and evaluated by target trial simulation (TTE) framework."},
{"id":"NCT07461051","registry":"ClinicalTrials.gov","slug":"effects-of-foot-bath-therapy-on-premenstrual-syndrome-nct07461051","match":"direct","title":"Effects of Foot Bath Therapy on Premenstrual Syndrome Symptoms, Quality of Life, and Pain","official_title":"The Effects of Footbath on Premenstrual Syndrome Symptoms, Quality of Life, and Pain: A Randomized Controlled Clinical Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Foot bath","Premenstrual Syndrome","Quality of life","pain"],"interventions":[{"type":"OTHER","name":"Foot bath therapy"}],"sponsor":"Agri Ibrahim Cecen University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":92,"enrollment_type":"ACTUAL","start_date":"2025-09-15","completion_date":"2026-06-01","first_posted":"2026-03-10","last_update":"2026-08-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07461051","reference_pmids":["17029646","9368198"],"brief_summary":"The study was conducted as a randomized controlled trial to evaluate the effects of foot bath application on symptom severity, quality of life, and pain levels in women with premenstrual syndrome. The research was carried out with 92 midwifery students. While foot bath therapy was applied to the experimental group, no intervention was performed in the control group. Data were collected through face-to-face interviews using the Personal Information Form, Premenstrual Symptom Scale, Visual Analog Scale, and SF-36 Quality of Life Scale."},
{"id":"NCT06771583","registry":"ClinicalTrials.gov","slug":"identification-and-validation-of-epigenetic-biomarkers-of-nct06771583","match":"direct","title":"Identification and Validation of Epigenetic Biomarkers of PMDD","official_title":"Identification and Validation of Epigenetic Biomarkers of PMDD","acronym":"BIO","status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["PMDD","Premenstrual Dysphoric Disorder (PMDD)","Premenstrual Syndrome-PMS","Premenstrual Syndrome","Menstrual Cycle"],"keywords":["menstrual cycle","pms","luteal phase","womens health","reproductive health","reproductive mental health","epigenetics","dna methylation","premenstrual","pmdd","women"],"interventions":[],"sponsor":"Johns Hopkins University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":500,"enrollment_type":"ESTIMATED","start_date":"2025-09-12","completion_date":"2031-02-15","first_posted":"2025-01-13","last_update":"2026-05-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06771583","reference_pmids":[],"brief_summary":"This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this study aim to determine if these biomarkers also distinguish PMDD cases from healthy controls at different points in the menstrual cycle. By collecting biological samples (such as blood) and monitoring mood changes across the menstrual cycle, the investigators will be able to determine whether these epigenetic markers are associated with PMDD. The investigators plan to study these epigenetic markers during the follicular phase (roughly the first half of the menstrual cycle, from menses until ovulation) and the luteal phase (roughly the second half of the menstrual cycle, from ovulation to menses). The investigators will study this in two groups: 1) individuals who do NOT have premenstrual mood symptoms, and 2) individuals with premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD). The results will provide a comprehensive view of the changes in these systems across the menstrual cycle. This will add to the investigators understanding of the mechanisms that may cause PMS/PMDD."},
{"id":"NCT07013539","registry":"ClinicalTrials.gov","slug":"efficacy-of-a-food-supplement-in-relieving-premenstrual-nct07013539","match":"direct","title":"Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms","official_title":"Clinical Evaluation of the Efficacy of a Food Supplement in Relieving Premenstrual Syndrome (PMS) Symptoms: a Randomized, Double-blind, Parallel-group, Placebo-controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"plant extract"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"sponsor":"Activ'inside","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Italy"],"enrollment":110,"enrollment_type":"ACTUAL","start_date":"2025-09-01","completion_date":"2026-05-15","first_posted":"2025-06-10","last_update":"2026-06-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07013539","reference_pmids":[],"brief_summary":"The aim of this clinical trial, funded by Activ'Inside, is to evaluate the efficacy of a food supplement in relieving Premenstrual Syndrome (PMS) Symptoms. The study will be performed on 110 healthy women who experience mild/moderate Premenstrual Syndrome (PMS) symptoms, under the supervision of a board-certified Gynecologist. Half of the subjects will assume the active product and half of the subjects will assume a placebo (a product without active ingredients). Specific assessments will be carried out before and after 1, 2 and 3 menstrual cycles of product intake. Also, the possible occurrence of adverse events will be recorded."},
{"id":"NCT07737210","registry":"ClinicalTrials.gov","slug":"effect-of-electroacupuncture-on-premenstrual-syndrome-in-nct07737210","match":"direct","title":"Effect of Electroacupuncture on Premenstrual Syndrome in Young Women","official_title":"Effect of Electroacupuncture on Premenstrual Syndrome in Young Women","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Nutritional Supplement"},{"type":"DEVICE","name":"electroacupuncture"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"2025-08-31","completion_date":"2026-01-30","first_posted":"2026-07-30","last_update":"2026-07-30","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07737210","reference_pmids":[],"brief_summary":"The aim of this study was to determine the effect of electroacupuncture on premenstrual syndrome in young women."},
{"id":"NCT07097181","registry":"ClinicalTrials.gov","slug":"the-effect-of-sensory-awareness-education-on-female-students-nct07097181","match":"direct","title":"The Effect of Sensory Awareness Education on Female Students' Body Awareness and Premenstrual Symptom Levels","official_title":"The Effect of Sensory Awareness Education on Female Students' Body Awareness and Premenstrual Symptom Levels","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["for Girls","Sensory Awareness Training","Body Awareness","Premenstrual Syndrome","Effect"],"keywords":["sensory awareness","education","student","premenstrual syndrome"],"interventions":[{"type":"BEHAVIORAL","name":"web-based sensory awareness training"}],"sponsor":"Saglik Bilimleri Universitesi","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":180,"enrollment_type":"ESTIMATED","start_date":"2025-08-31","completion_date":"2025-12-31","first_posted":"2025-07-31","last_update":"2025-07-31","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07097181","reference_pmids":[],"brief_summary":"This research investigates the effects of web-based sensory awareness training on female students' body movements. In order to examine its effect on awareness and premenstrual symptom levels. planned. H0a = Body awareness levels of female students who receive and do not receive sensory awareness training. There is no difference between. H1a = Body awareness levels of female students who receive and do not receive sensory awareness training. There is a difference between . H0b = Premenstrual symptoms of female students who received and did not receive sensory awareness training. There is no difference between the levels. H1b = Premenstrual symptoms of female students who receive and do not receive sensory awareness training. There is a difference between the levels. Participants will be given sensory awareness training for 4 weeks and female students will be given \"Premenstrual Syndrome Scale\" and \"Very\" before the training and 4 weeks after the first training.Dimensional Body Awareness Assessment-II Scale\" will be applied"},
{"id":"NCT07097558","registry":"ClinicalTrials.gov","slug":"mandala-and-music-for-pms-relief-nct07097558","match":"direct","title":"Mandala and Music for PMS Relief","official_title":"The Effect of Mandala Coloring and Music Listening on Premenstrual Syndrome Symptoms and Quality of Life: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Mandala Coloring","Music Listening","Premenstrual Syndrome-PMS"],"keywords":["Music Listening","music","art therapy","mandala coloring","Premenstrual Syndrome"],"interventions":[{"type":"OTHER","name":"Mandala coloring group"},{"type":"OTHER","name":"Music listening group"},{"type":"OTHER","name":"control group"}],"sponsor":"Rukiye Duman","sponsor_class":"OTHER","collaborators":["The Scientific and Technological Research Council of Turkey"],"countries":["Turkey (Türkiye)"],"enrollment":108,"enrollment_type":"ACTUAL","start_date":"2025-08-13","completion_date":"2026-05-01","first_posted":"2025-07-31","last_update":"2026-07-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07097558","reference_pmids":[],"brief_summary":"Purpose: The aim of this project is to examine the effects of mandala painting and music performance interventions on premenstrual syndrome symptoms and quality of life. The hypotheses of the study are as follows: Coloring mandalas has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on quality of life. Coloring mandalas has a positive effect on quality of life."},
{"id":"NCT06496139","registry":"ClinicalTrials.gov","slug":"emotion-regulation-based-internet-delivered-cognitive-nct06496139","match":"direct","title":"Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder","official_title":"Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial","acronym":"Premensis-s","status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["Internet-delivered cognitive behavioural therapy","Emotion regulation","Premenstrual dysphoric disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Therapist-guided internet-delivered cognitive behavioural therapy"}],"sponsor":"Uppsala University","sponsor_class":"OTHER","collaborators":["Friedrich-Alexander-Universität Erlangen-Nürnberg","Utah State University","Linkoeping University"],"countries":["Sweden"],"enrollment":164,"enrollment_type":"ESTIMATED","start_date":"2025-07-14","completion_date":"2028-07","first_posted":"2024-07-11","last_update":"2025-07-31","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06496139","reference_pmids":["39843366"],"brief_summary":"Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed. Preliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT)."},
{"id":"NCT07737366","registry":"ClinicalTrials.gov","slug":"the-efficacy-of-lavender-herbal-tea-in-premenstrual-syndrome-nct07737366","match":"direct","title":"The Efficacy of Lavender Herbal Tea in Premenstrual Syndrome","official_title":"Psychological and Physiological Effects of Lavender Herbal Tea in Women With Premenstrual Syndrome: a Randomized Clinical Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome","Anxiety","Depression","Stress","Pain Measurement","Complementary Medicine","Bleeding"],"keywords":["premenstrual syndrome","anxiety","depression","stress","pain measurement","lavender","complementary medicine"],"interventions":[{"type":"OTHER","name":"Lavender herbal tea"}],"sponsor":"Sakarya University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"2025-07-09","completion_date":"2025-10-18","first_posted":"2026-07-30","last_update":"2026-10-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07737366","reference_pmids":["21171936","2382749","29855308","30774727","31969927","36317488","37335817"],"brief_summary":"Premenstrual syndrome (PMS) is a common but complex condition defined as a combination of emotional, psychological, and physical symptoms that occur during the luteal phase of the menstrual cycle, usually between 2 and 14 days before the onset of menstruation, and that diminish with menstruation. Epidemiological studies have reported that 80-90% of women experience premenstrual syndrome symptoms, with approximately 20-40% reported to affect daily functioning and relationships. Symptoms associated with PMS include irritability, mood swings, anxiety, depression, bloating, breast tenderness, and headaches. Pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological methods such as dietary changes, exercise, and cognitive behavioral therapy are used in the management of PMS symptoms. Complementary herbal therapies are gaining increasing interest among individuals who want to avoid the side effects of traditional pharmacological agents. Various agents such as Vitex agnus-castus (chaste tree), Hypericum perforatum (St John's wort), evening primrose oil, and conventional herbal formulations have been studied in the literature. Vitex agnus-castus was found to be effective in relieving PMS symptoms by regulating hormonal balance. The antidepressant effects of yellow cantharone have been evaluated, but findings on its efficacy are inconsistent. Evening primrose oil shows particularly favorable effects on cyclic mastalgia. Lavender tea is known to reduce depression, anxiety, and mood swings. There are no clinical studies evaluating the effect of lavender tea on menstrual bleeding. A randomized controlled trial has shown that abdominal massage with lavender oil reduces the severity of menstrual pain. In this context, it may be a potential complementary herbal treatment to relieve PMS symptoms. Therefore, women with PMS will be divided into two groups. The intervention group will use 2 grams of lavender tea 2 times a day, morning and evening, for 9 days during 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation). The control group will create a waiting list. The study data will be provided by 'Personal Information Form', 'Premenstrual Syndrome Scale', 'Depression Anxiety Stress-21 Scale', 'Premenstrual Syndrome Specific Quality of Life Scale', Visual Analogue Scale (VAS), and pad follow-up to monitor bleeding. SPSS 25.0 software will be used to analyze the data obtained from the study. Although the effects of lavender tea on PMS are promising, more clinical studies are needed to confirm its effectiveness. With this study, the need for clinical studies on the effectiveness of lavender tea will be met and a natural and complementary treatment method that can alleviate PMS symptoms will be tested."},
{"id":"NCT07655466","registry":"ClinicalTrials.gov","slug":"effects-of-seed-cycling-capsules-on-premenstrual-syndrome-nct07655466","match":"direct","title":"Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length","official_title":"Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Menstrual Symptoms"],"keywords":["Hormonal Imbalance","Menstrual Health"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Two Moons Seed Cycling Capsules"}],"sponsor":"Superlune Inc. d/b/a Two Moons Health","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2025-07-08","completion_date":"2025-09-27","first_posted":"2026-06-17","last_update":"2026-06-17","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07655466","reference_pmids":[],"brief_summary":"This virtual, single-arm clinical trial will evaluate the effects of Seed Cycling Capsules on symptoms associated with premenstrual syndrome (PMS) and menstrual cycle characteristics. Forty female participants aged 18 to 45 years will use the study products daily for two menstrual cycles. Participants will complete questionnaires at baseline, at the end of their period during Cycle 1, and at the end of their period during Cycle 2."},
{"id":"NCT06961552","registry":"ClinicalTrials.gov","slug":"the-effect-of-reflexology-on-premenstrual-syndrome-symptoms-nct06961552","match":"direct","title":"The Effect of Reflexology on Premenstrual Syndrome Symptoms, Pain and Quality of Life","official_title":"The Effect of Reflexology on Premenstrual Syndrome Symptoms, Pain and Quality of Life","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Effect of Reflexology on Premenstrual Syndrome Symptoms"],"keywords":["reflexology","Premenstrual Syndrome-PMS","Pain","Quality of Life"],"interventions":[{"type":"OTHER","name":"reflexology masaj group"}],"sponsor":"Saglik Bilimleri Universitesi","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":70,"enrollment_type":"ESTIMATED","start_date":"2025-07-01","completion_date":"2025-12-30","first_posted":"2025-05-08","last_update":"2025-05-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06961552","reference_pmids":[],"brief_summary":"This study was planned as a randomized controlled experimental study to examine the effect of reflexology on premenstrual syndrome symptoms, pain and quality of life in women with premenstrual syndrome between January 2025 and December 2025. A total of 70 women, 35 in the experimental group and 35 in the control group, who applied to the gynecology outpatient clinic with premenstrual syndrome symptoms, met the inclusion criteria and agreed to participate in the study voluntarily will constitute the sample. The women in the reflexology group will receive a reflexology massage for two cycles by the researcher, starting at the end of menstruation (on the 5th-7th days of the cycle), for a total of 30 minutes, with proven applications specific to the region, pressure sliding and circular pressure applied to the reflexology distribution points on the foot bones three times, with baby oil. A total of 8 reflexology massage sessions will be performed, one day a week (Monday) for 8 weeks, one session. No intervention will be made to the control group."},
{"id":"NCT07084714","registry":"ClinicalTrials.gov","slug":"moderate-aerobic-exercise-for-managing-menstrual-cycle-nct07084714","match":"direct","title":"Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms","official_title":"Impact of Moderate Aerobic Exercise on Menstrual Cycle Symptoms in Sedentary Women","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Menstrual Cycle","Menstrual Distress (Dysmenorrhea)","Menstrual Bleeding, Heavy"],"keywords":["menstrual cycle","premenstrual syndrome","dysmenorrhea"],"interventions":[{"type":"BEHAVIORAL","name":"Moderate Aerobic Exercise"}],"sponsor":"University of Colorado, Colorado Springs","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":35,"enrollment_type":"ESTIMATED","start_date":"2025-07","completion_date":"2026-08","first_posted":"2025-07-24","last_update":"2025-07-24","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07084714","reference_pmids":[],"brief_summary":"The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles."},
{"id":"NCT07118553","registry":"ClinicalTrials.gov","slug":"factors-affecting-premenstrual-syndrome-nct07118553","match":"direct","title":"Factors Affecting Premenstrual Syndrome","official_title":"The Effect of Facial Massage on Quality of Life, Mood, Pain and Stress Levels in Women With Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["premenstrual syndrome","face","massage","quality of life"],"interventions":[{"type":"OTHER","name":"classic facial massage"}],"sponsor":"Trabzon University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":27,"enrollment_type":"ACTUAL","start_date":"2025-05-14","completion_date":"2025-06-20","first_posted":"2025-08-12","last_update":"2025-08-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07118553","reference_pmids":[],"brief_summary":"Premenstrual pain syndrome is a common problem that affects many women of reproductive age. In this study, we aimed to determine whether facial massage would improve the quality of life, mood, pain and stress levels of women with premenstrual syndrome."},
{"id":"NCT06704594","registry":"ClinicalTrials.gov","slug":"allopregnanolone-and-dynamic-gaba-a-receptor-plasticity-in-nct06704594","match":"direct","title":"Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder","official_title":"Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder","acronym":"BLOOM","status":"RECRUITING","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder (PMDD)"],"keywords":["pmdd","premenstrual dysphoric disorder","pms","premenstrual symptoms","premenstrual syndrome","blood draw","sertraline","ssri","mood symptoms","women","women with pms","women with pmdd","luteal phase","follicular phase","womens reproductive mental health","womens health","womens reproductive health","menstrual cycle","menses","periods","allopregnanolone","neuroactive steroids","inflammatory markers","epigenetics"],"interventions":[{"type":"DRUG","name":"sertraline 50 mg daily"},{"type":"DRUG","name":"Placebo Oral Tablet"}],"sponsor":"Johns Hopkins University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":288,"enrollment_type":"ESTIMATED","start_date":"2025-05-14","completion_date":"2029-07-01","first_posted":"2024-11-26","last_update":"2026-05-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06704594","reference_pmids":[],"brief_summary":"Premenstrual dysphoric disorder (PMDD) is a severe affective disorder impacting millions of women worldwide, thought to be due to altered sensitivity to hormone fluctuations across the menstrual cycle. Neuroactive steroid hormones (NAS) and the gamma-aminobutyric acid (GABA)-A receptor (GABAAR) are thought to play a role in PMDD. This research will assess the blood levels of GABAergic NAS, expression of associated enzymes, and expression of GABAAR subunits across the premenstrual (luteal) phase of the menstrual cycle in healthy controls and individuals with PMDD. Within the PMDD group, the investigators will assess how these measures are affected by a low-dose antidepressant medication versus placebo. The results will provide a comprehensive view of the changes in these systems across the menstrual cycle and will add to the investigator's understanding of the mechanisms that underlie PMDD, as well as therapeutic mechanisms of PMDD treatment."},
{"id":"NCT06891638","registry":"ClinicalTrials.gov","slug":"enhancing-reading-recovery-in-aphasia-with-tdcs-and-nct06891638","match":"direct","title":"Enhancing Reading Recovery in Aphasia With tDCS and Phonomotor Therapy","official_title":"Enhancing Reading Recovery in Aphasia With tDCS and PMT","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Stroke","Aphasia"],"keywords":["Aphasia","Post-stroke rehabilitation","Reading impairment","Language therapy","Transcranial Direct Current Stimulation (tDCS)","Phonomotor Treatment (PMT)","Brain stimulation therapy","Neurorehabilitation","Randomized controlled trial (RCT)","Non-invasive brain stimulation","Neuromodulation","Speech and language therapy"],"interventions":[{"type":"DEVICE","name":"Schedule of tDCS administration"}],"sponsor":"Kessler Foundation","sponsor_class":"OTHER","collaborators":["Medical College of Wisconsin"],"countries":["United States"],"enrollment":6,"enrollment_type":"ACTUAL","start_date":"2025-05-12","completion_date":"2026-02-14","first_posted":"2025-03-24","last_update":"2026-05-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06891638","reference_pmids":[],"brief_summary":"This study is designed for individuals with aphasia, a language disorder that affects many stroke survivors, making it difficult to read, speak, and understand language. Up to 70% of people with aphasia struggle with reading, which impacts their ability to communicate, work, and engage in daily life. The study aims to test a new approach to reading rehabilitation by combining Phono-Motor Treatment (PMT), a language therapy adapted to improve reading, with transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique. tDCS delivers a mild electrical current to the brain, which may enhance learning. This study will assess whether adding tDCS to PMT improves reading therapy outcomes."},
{"id":"ISRCTN99520723","registry":"ISRCTN","slug":"sex-differences-in-interoception-and-mental-health-an-isrctn99520723","match":"related","title":"Sex differences in interoception and mental health: an investigation across the menstrual cycle","official_title":"Sex differences in interoception and mental health: an investigation across the menstrual cycle","acronym":null,"status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Identifying sex differences in interoception (i.e. the perception of the internal state of the body), common mental health disorders (i.e. anxiety, depression) and mood, and somatic complaints (i.e. physical symptoms), and identifying whether the menstrual cycle may contribute to these differences."],"keywords":["Mental and Behavioural Disorders"],"interventions":[{"type":"Behavioural","name":null}],"sponsor":"University of Surrey","sponsor_class":null,"collaborators":[],"countries":["Austria","Belgium","Bulgaria","Croatia","Cyprus","Czech Republic","Denmark","England","Estonia","Finland","France","Germany","Greece","Hungary","Ireland","Italy","Latvia","Lithuania","Luxembourg","Malta","Netherlands","Poland","Portugal","Romania","Slovakia","Slovenia","Spain","Sweden","United Kingdom"],"enrollment":0,"enrollment_type":"ACTUAL","start_date":"2025-05-06","completion_date":"2027-04-26","first_posted":"2024-12-19","last_update":null,"has_results":false,"results_url":null,"url":"https://www.isrctn.com/ISRCTN99520723","reference_pmids":[],"brief_summary":null},
{"id":"NCT07642232","registry":"ClinicalTrials.gov","slug":"effects-of-somatic-movement-therapy-vs-core-strengthening-in-nct07642232","match":"direct","title":"Effects of Somatic Movement Therapy vs Core Strengthening in Premenstrual Syndrome","official_title":"Effects of Somatic Movement Therapy Versus Core Strengthening Exercises on Symptom Severity, Perceived Stress, and Quality of Life in Premenstrual Syndrome","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Core Strengthening Exercises","Perceived Stress","Quality of Life","Somatic Movement Therapy"],"interventions":[{"type":"OTHER","name":"Group A (Somatic Movement Therapy)"},{"type":"OTHER","name":"Group B (Core Strengthening Exercise)"}],"sponsor":"Riphah International University","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":36,"enrollment_type":"ESTIMATED","start_date":"2025-05-05","completion_date":"2026-08-15","first_posted":"2026-06-11","last_update":"2026-06-11","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07642232","reference_pmids":["26352222","35534402","35574174","38004093"],"brief_summary":"Premenstrual Syndrome (PMS) is a multifactorial disorder affecting women of reproductive age, causing physical discomfort, emotional instability, and reduced quality of life. This randomized clinical trial aims to compare the effects of Somatic Movement Therapy (SMT) and Core Strengthening Exercises (CSE) on symptom severity, perceived stress, and quality of life in 34 female participants aged 18-35 years diagnosed with PMS according to ACOG criteria. Group A will receive SMT, while Group B will perform CSE over a 6-week program. Outcomes will be measured using PSST, PSS-10, and WHOQOL-BREF, with data analyzed through SPSS version 27."},
{"id":"NCT06756477","registry":"ClinicalTrials.gov","slug":"the-effect-of-mindfulness-training-on-premenstrual-syndrome-nct06756477","match":"direct","title":"The Effect of Mindfulness Training on Premenstrual Syndrome Symptoms and Quality of Life","official_title":"The Effect of Mindfulness-Based Healthy Living Behaviors Training on Premenstrual Syndrome Symptoms and Quality of Life","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Mindfulness","Premenstrual Syndrome-PMS","Quality of Life"],"keywords":["Mindfulness-Based Education","Healthy Living Behaviours","Premenstrual Syndrome Symptoms","Quality of Life","Midwifery"],"interventions":[{"type":"BEHAVIORAL","name":"mindfulness group"},{"type":"OTHER","name":"control group"}],"sponsor":"Nisan Akçay","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":114,"enrollment_type":"ACTUAL","start_date":"2025-05-03","completion_date":"2025-08-03","first_posted":"2025-01-03","last_update":"2025-12-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06756477","reference_pmids":["31743957","31985138","32026721","32105790","32406186","32911210","33315046","33475550","33915368","34058560","34475764","34900066","35149373","35257692","35745189","35782413","36032464","36824400","37227541","37342975","37711728","38350849"],"brief_summary":"Premenstrual syndrome (PMS) is an important health problem that negatively affects women's quality of life by reducing their daily activities, sleep quality, cognitive functioning, interpersonal relationships, academic performance, work and school attendance. Studies show that PMS is associated with unhealthy life behaviors and that PMS can be reduced through the development of healthy life behaviors. Midwives can benefit from mindfulness-based programs while providing quality health care services to develop a healthy lifestyle in the prevention and treatment of PMS in women. In the literature, there is no study examining the effectiveness of mindfulness-based healthy life behaviors training on PMS. To the best of our knowledge, our study is the first study to examine the effect of a mindfulness-based healthy life behaviors training program on premenstrual syndrome symptoms and quality of life."},
{"id":"NCT06981533","registry":"ClinicalTrials.gov","slug":"auricular-acupressure-for-premenstrual-syndrome-in-female-nct06981533","match":"direct","title":"Auricular Acupressure for Premenstrual Syndrome in Female Students","official_title":"Efficacy of Auricular Acupressure in Treating Premenstrual Syndrome in Female Undergraduate Students","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Auricular Acupressure","Female undergraduate students","PMS","The Premenstrual Symptoms Screening Tool"],"interventions":[{"type":"OTHER","name":"Auricular acupressure therapy"},{"type":"OTHER","name":"Sham auricular acupressure therapy"},{"type":"OTHER","name":"Lifestyle modifications"}],"sponsor":"University of Medicine and Pharmacy at Ho Chi Minh City","sponsor_class":"OTHER","collaborators":[],"countries":["Vietnam"],"enrollment":66,"enrollment_type":"ACTUAL","start_date":"2025-04-20","completion_date":"2025-09-30","first_posted":"2025-05-20","last_update":"2026-06-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06981533","reference_pmids":["24410911","29033988","30105749","31341497","35167949"],"brief_summary":"Premenstrual Syndrome (PMS) is a common gynecological disorder that significantly affects the quality of life for women of reproductive age, with symptoms including emotional, behavioral, and physical disturbances occurring approximately one week before menstruation. PMS is especially prevalent among female undergraduate students, who often experience heightened stress due to academic pressures and lack emotional coping strategies. While pharmacological treatments, such as SSRIs and hormonal therapies, have been used to manage PMS symptoms, they may have side effects and are not always effective in the long term. This has led to increasing interest in alternative treatments such as traditional medicine. Auricular acupressure, a non-invasive and low-risk method, has shown promising results in managing PMS symptoms and is gaining attention as a possible solution. The goal of this clinical trial is to evaluate the efficacy and safety of auricular acupressure in reducing PMS symptoms in female undergraduate students. The main questions it aims to answer are: * Does auricular acupressure reduce the severity of PMS symptoms in female undergraduate students? * Is auricular acupressure safe and well-tolerated by participants? Researchers will compare the intervention group (receiving auricular acupressure) to the control group (receiving sham auricular acupressure) to see if auricular acupressure has a significant impact on reducing PMS symptoms and improving quality of life. Participants will: * Receive auricular acupressure on specific acupoints or sham treatment. * Complete assessments of PMS symptoms using the Premenstrual Symptoms Screening Tool (PSST) at baseline, 1 week, and 8 weeks. * Complete a quality of life assessment using the WHOQOL-Bref scale at the same time points. * Be monitored for any adverse effects during the 8-week trial period."},
{"id":"NCT07040553","registry":"ClinicalTrials.gov","slug":"effect-of-motivational-interviewing-and-digital-support-on-nct07040553","match":"direct","title":"Effect of Motivational Interviewing and Digital Support on Premenstrual Symptoms and Emotion Regulation","official_title":"The Effect of an 8-Week Motivational Interviewing and Weekly Digital Messaging Intervention on Premenstrual Symptoms and Emotion Regulation in Female University Students: A Randomized Controlled Trial","acronym":"MIND-PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome-PMS","Emotion Regulation"],"keywords":["Premenstrual Syndrome","Emotion Regulation","Motivational Interviewing","WhatsApp Intervention","Digital Health","University Students","Young Women","Randomized Controlled Trial","Women&#39;s health"],"interventions":[{"type":"BEHAVIORAL","name":"Motivational Interviewing and WhatsApp Support"}],"sponsor":"Aydin Adnan Menderes University","sponsor_class":"OTHER","collaborators":["Erzurum Technical University"],"countries":["Turkey (Türkiye)"],"enrollment":70,"enrollment_type":"ACTUAL","start_date":"2025-04-14","completion_date":"2025-06-05","first_posted":"2025-06-27","last_update":"2025-06-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07040553","reference_pmids":["38133631"],"brief_summary":"This randomized controlled trial aims to evaluate the effectiveness of an 8-week support program that combines face-to-face motivational interviewing with weekly WhatsApp messages in reducing premenstrual syndrome (PMS) symptoms and improving emotion regulation among university students. The study was conducted with 70 female students enrolled in the Nursing Department of Erzurum Technical University in Türkiye. Eligible participants are identified using the Premenstrual Syndrome Scale (PMSS), and those scoring above 110 are considered to have PMS. Students who meet the inclusion criteria and volunteer to participate are randomly assigned to either the intervention group (n=35) or the control group (n=35), using a computer-based randomization tool. Housing locations (e.g., dorm rooms or homes) are considered to prevent cross-contamination between groups. All participants complete three forms: a Personal Information Form (to gather data on sociodemographic, menstrual, and lifestyle characteristics), the PMSS (to assess PMS severity), and the Difficulties in Emotion Regulation Scale - Short Form (DERS-16). These are completed before the intervention and again at 8 weeks. The intervention group receives weekly one-on-one motivational interviews and supportive WhatsApp messages based on the principles of Motivational Interviewing as defined by Miller and Rollnick (2012). No medical treatments or devices are used in this study. Participation is voluntary, and informed written consent is obtained from all students. Ethical approval was granted by the Ethics Committee of Erzurum Technical University."},
{"id":"NCT06909955","registry":"ClinicalTrials.gov","slug":"the-effect-of-progressive-muscle-relaxation-exercises-on-nct06909955","match":"direct","title":"The Effect of Progressive Muscle Relaxation Exercises on Premenstrual Syndrome, Anxiety, and Tendency to Violence in Young Women","official_title":"The Effect of Progressive Muscle Relaxation Exercises on Premenstrual Syndrome, Anxiety, and Tendency to Violence in Young Women","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Disorder"],"keywords":["premenstrual syndrome","progressive relaxation exercise"],"interventions":[{"type":"OTHER","name":"Exercise"}],"sponsor":"Istanbul Medipol University Hospital","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":84,"enrollment_type":"ACTUAL","start_date":"2025-04-01","completion_date":"2025-09-01","first_posted":"2025-04-04","last_update":"2026-10-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06909955","reference_pmids":[],"brief_summary":"This study results will provide evidence on the effectiveness of Progressive Muscle Relaxation Exercises (PMRE) as a complementary method in improving Premenstrual Syndrome (PMS), an important women's health issue. Additionally, it will contribute to the literature by shedding light on irritability and anxiety, which are common side effects of PMS."},
{"id":"NCT06906133","registry":"ClinicalTrials.gov","slug":"sleep-quality-and-the-menstrual-cycle-nct06906133","match":"related","title":"Sleep Quality and the Menstrual Cycle","official_title":"Comparing Changes in Objective Measures of Sleep Quality During the Menstrual Cycle in Healthy Women: Association With Ovarian Hormones and Mood","acronym":null,"status":"ACTIVE_NOT_RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Sleep Quality"],"keywords":["Objectively measured sleep","Sleep quality","Sleep disorder breathing","Ovarian hormones","Mood","Menstrual cycle","Sleep duration"],"interventions":[{"type":"OTHER","name":"Urinary-hCG"}],"sponsor":"University of Akureyri","sponsor_class":"OTHER","collaborators":["Akureyri Hospital"],"countries":["Iceland"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2025-03-01","completion_date":"2026-08-31","first_posted":"2025-04-02","last_update":"2025-04-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06906133","reference_pmids":["18064739","21493134","26429749","29679598","35422659","36217085","37356456"],"brief_summary":"This study aims to examine how ovarian hormone fluctuations across the menstrual cycle affect sleep patterns. Using objective sleep tracking, hormone phase assessment, and validated questionnaires, it will assess changes in sleep quality, duration, menstrual symptoms, sleepiness, chronotype, anxiety, and depression over one full cycle."},
{"id":"NCT06724419","registry":"ClinicalTrials.gov","slug":"efficacy-of-nutrition-education-in-alleviating-premenstrual-nct06724419","match":"direct","title":"Efficacy of Nutrition Education in Alleviating Premenstrual Syndrome (PMS) Among Chinese College Students at Hainan University, China","official_title":"Efficacy of Nutrition Education in Alleviating Premenstrual Syndrome (PMS) Among Chinese College Students at Hainan University, China","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome-PMS"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Nutrition education-based intervention"}],"sponsor":"Universiti Tunku Abdul Rahman","sponsor_class":"OTHER","collaborators":[],"countries":["China"],"enrollment":210,"enrollment_type":"ACTUAL","start_date":"2025-02-24","completion_date":"2025-07-04","first_posted":"2024-12-09","last_update":"2026-04-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06724419","reference_pmids":[],"brief_summary":"This study aims to evaluate the efficacy of nutrition education-based intervention on PMS severity, perceived stress, and lifestyle-related outcomes among the students at Hainan Vocational University of Science and Technology"},
{"id":"NCT06832293","registry":"ClinicalTrials.gov","slug":"my-ms-and-my-menstrual-cycle-nct06832293","match":"related","title":"My MS and My Menstrual Cycle","official_title":"Measuring MS Symptoms in Relation to Menstrual Cycles: Exploring How MS Symptoms May be Affected at Different Times During a Menstrual Cycle in Females Living With Multiple Sclerosis","acronym":null,"status":"SUSPENDED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Multiple Sclerosis","Menstrual Cycle"],"keywords":["Multiple Sclerosis","Menstrual Cycle","MS Symptoms","Fatigue","Cognition"],"interventions":[],"sponsor":"University of Alberta","sponsor_class":"OTHER","collaborators":[],"countries":["Canada"],"enrollment":300,"enrollment_type":"ESTIMATED","start_date":"2025-02-19","completion_date":"2027-01-31","first_posted":"2025-02-18","last_update":"2026-04-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06832293","reference_pmids":[],"brief_summary":"The goal of this observational study is to understand how MS symptoms change during different phases of the menstrual cycle in individuals who menstruate living with MS (Multiple Sclerosis). The main questions it aims to answer are: 1. Does fatigue get worse during certain phases of the menstrual cycle? 2. How do symptoms like thinking skills, pain, and mobility change throughout the cycle? Participants will: * Use the My Normative app to track their menstrual cycle and MS symptoms. * Complete symptom check-ins at five points during their cycle for six months. * Answer questions about fatigue, thinking skills, mood, sleep, and other MS symptoms at the start and end of the study. These findings may help researchers better understand MS symptom patterns and improve symptom management."},
{"id":"NCT06785766","registry":"ClinicalTrials.gov","slug":"effects-of-yoga-on-balance-cognition-posture-and-body-nct06785766","match":"direct","title":"Effects of Yoga on Balance, Cognition, Posture, and Body Awareness in Premenstrual Syndrome (PMS)","official_title":"Investigating the Effects of Yoga-Based Exercises on Balance, Cognitive Function, Posture, and Body Awareness in Young Adults With Premenstrual Syndrome","acronym":null,"status":"ENROLLING_BY_INVITATION","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":["Quality of life","Premenstrual Syndrome","Yoga","Pain","Cognitive Function","Body Awareness"],"interventions":[{"type":"BEHAVIORAL","name":"Yoga-Based Exercise Program"}],"sponsor":"Izmir Democracy University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2025-02-15","completion_date":"2026-06-30","first_posted":"2025-01-21","last_update":"2025-01-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06785766","reference_pmids":["14992161","25669217","28081191","31000345","35755198"],"brief_summary":"Premenstrual syndrome (PMS) is characterized by a combination of cognitive, somatic, behavioral, and emotional disorders that occur during the late luteal phase of the menstrual cycle, resolve rapidly after menstruation, and can be severe enough to disrupt daily activities. When reviewing the literature, studies examining the effects of yoga-based exercises on premenstrual syndrome appear to be quite limited. Our aim is to raise awareness among professionals working in this field in our country, contributing to the reduction of symptoms and improvement of the quality of life of individuals with premenstrual syndrome."},
{"id":"NCT07461766","registry":"ClinicalTrials.gov","slug":"food-and-nutrition-education-for-adolescent-soccer-players-nct07461766","match":"direct","title":"Food and Nutrition Education for Adolescent Soccer Players","official_title":"Food and Nutrition Education for Adolescent Soccer Players: Influence on Eating Habits and Promotion of Women's Health","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"PREVENTION","conditions":["Nutritional Assessments","Adolescent Athletic Performance","Premenstrual Syndrome"],"keywords":["adolescent athletes","nutritional education","body composition","premenstrual symptoms"],"interventions":[{"type":"BEHAVIORAL","name":"nutritional education"}],"sponsor":"Federal University of São Paulo","sponsor_class":"OTHER","collaborators":[],"countries":["Brazil"],"enrollment":50,"enrollment_type":"ACTUAL","start_date":"2025-02-01","completion_date":"2025-11-30","first_posted":"2026-03-10","last_update":"2026-03-10","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07461766","reference_pmids":[],"brief_summary":"To identify changes in eating habits and symptoms of premenstrual tension in adolescent athletes before and after a nutritional education program."},
{"id":"NCT07267728","registry":"ClinicalTrials.gov","slug":"a-clinical-study-to-assess-the-effect-of-a-dietary-nct07267728","match":"direct","title":"A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms","official_title":"A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Menstrual Pain"],"keywords":["Bloating","Mood Disorders"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"DITTO Cycle Supplement"}],"sponsor":"Muse Nutrition Ltd","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2025-02-01","completion_date":"2025-07-01","first_posted":"2025-12-05","last_update":"2026-08-17","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07267728","reference_pmids":["42699717"],"brief_summary":"This is a single-group, virtual clinical trial evaluating the effects of a daily dietary supplement (DITTO Cycle Supplement) on menstrual cycle symptoms across three menstrual cycles. The study investigates changes in symptom severity through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ), and proportion of participants experiencing symptom reduction."},
{"id":"NCT06925022","registry":"ClinicalTrials.gov","slug":"educational-programs-based-on-healthy-habits-to-improve-nct06925022","match":"related","title":"Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study (Phase 1)","official_title":"Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study","acronym":"ADVICE Phase 1","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Multiple Sclerosis (MS) - Relapsing-remitting"],"keywords":["Lifestyle Interventions","Menstrual Cycle","Multiple Sclerosis","Exercise","Cognitive-behavioral intervention","Physical Activity, Psychosocial Well-being","Nutrition intervention"],"interventions":[{"type":"OTHER","name":"Strength training session during Early Follicular Phase"},{"type":"OTHER","name":"Strength Training Protocol during Late Follicular Phase"},{"type":"OTHER","name":"Strength Training during Mid-Luteal Phase"}],"sponsor":"Universidad de Almeria","sponsor_class":"OTHER","collaborators":["Catholic University of Murcia","Hospital Universitario Virgen de la Arrixaca"],"countries":["Spain"],"enrollment":20,"enrollment_type":"ACTUAL","start_date":"2024-12-15","completion_date":"2026-06-30","first_posted":"2025-04-13","last_update":"2026-07-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06925022","reference_pmids":[],"brief_summary":"This phase of the project aims to analyze the interaction between physical exercise and the phases of the menstrual cycle, evaluating its impact on fatigue, functional capacity, and exercise perception in women with and without Multiple Sclerosis. To achieve this, a controlled, single-blind, prospective, 2x3 crossover, randomized clinical trial will be conducted, involving women with Multiple Sclerosis (MS), matched by age, lifestyle habits (smoking, physical activity), and geographic location with a group of women without MS. This study, aligned with previous findings, seeks to deepen the understanding of the role of exercise in managing Multiple Sclerosis symptoms and to promote greater adherence to personalized physical activity programs adapted to the phases of the menstrual cycle."},
{"id":"NCT06462391","registry":"ClinicalTrials.gov","slug":"adapting-and-piloting-acceptance-and-commitment-therapy-act-nct06462391","match":"direct","title":"Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms","official_title":"Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms: An Open-label Feasibility Study of ACT-PM","acronym":"ACT-PM","status":"ACTIVE_NOT_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"OTHER","conditions":["Premenstrual Dysphoric Disorder","Premenstrual Exacerbation of Mood Disorder"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Acceptance and Commitment Therapy (ACT) Group"}],"sponsor":"Women's College Hospital","sponsor_class":"OTHER","collaborators":[],"countries":["Canada"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2024-12-01","completion_date":"2026-12-31","first_posted":"2024-06-17","last_update":"2025-12-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06462391","reference_pmids":[],"brief_summary":"In the weeks prior to menstruation, many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning. Approximately 5% of women and menstruating individuals have such severe symptoms that they meet criteria for Premenstrual Dysphoric Disorder (PMDD). Further, of those with underlying mood disorders (i.e., depression, bipolar disorder) about 60% have cyclical worsening of symptoms classified as premenstrual exacerbation (PME). Both PMDD and PME are associated with significant impairment, yet limited effective options exist to treat these conditions. In this project, the investigators will adapt and evaluate an Acceptance and Commitment Therapy (ACT) group for PMDD and PME, entitled ACT-Premenstrual (ACT-PM), delivered virtually to maximize accessibility. The investigators will examine whether ACT-PM is feasible to deliver and whether it is acceptable to group participants and those facilitating the group. The study will lay the groundwork for future research to determine if the group is effective. If effective, the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from PMDD and PME."},
{"id":"NCT06644365","registry":"ClinicalTrials.gov","slug":"acupressure-mat-on-perceived-stress-sleep-quality-and-nct06644365","match":"direct","title":"Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms","official_title":"Examining the Effect of Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms in Students Experiencing Premenstrual Syndrome: Randomized Controlled Study","acronym":null,"status":"NOT_YET_RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Symptoms","Effect of Acupressure Mat"],"keywords":[],"interventions":[{"type":"OTHER","name":"Acupresure mat"},{"type":"OTHER","name":"Basic mat"}],"sponsor":"Gulhane School of Medicine","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":42,"enrollment_type":"ESTIMATED","start_date":"2024-11-15","completion_date":"2025-03-30","first_posted":"2024-10-16","last_update":"2024-10-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06644365","reference_pmids":[],"brief_summary":"Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome. Hypotheses of the study; In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat; H10: There is no difference in terms of severity of premenstrual symptoms. H20: There is no difference in terms of perceived stress. H30: There is no difference in terms of sleep quality."},
{"id":"NCT06665347","registry":"ClinicalTrials.gov","slug":"effect-of-yoga-on-psychological-aspect-and-quality-of-life-nct06665347","match":"direct","title":"Effect of Yoga on Psychological Aspect and Quality of Life in Premenstrual Syndrome","official_title":"Effect of Yoga on Psychological Aspect and Quality of Life in Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Progressive muscle relaxation"},{"type":"OTHER","name":"Yoga"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":46,"enrollment_type":"ACTUAL","start_date":"2024-11-02","completion_date":"2025-06-30","first_posted":"2024-10-30","last_update":"2025-07-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06665347","reference_pmids":[],"brief_summary":"This study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome."},
{"id":"NCT06615648","registry":"ClinicalTrials.gov","slug":"effectiveness-of-a-pmt-intervention-to-reduce-alcohol-in-nct06615648","match":"direct","title":"Effectiveness of a PMT Intervention to Reduce Alcohol in Young Adults","official_title":"The Effectiveness of the Protection Motivation Theory in Reducing Alcohol-Related Intentions and Behaviours Among Young Adults","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Behavior, Drinking","Alcohol Drinking","Colorectal Cancer Control and Prevention","Healthy Volunteers"],"keywords":["Protection Motivation Theory","Alcohol","Alcohol Intention","Alcohol Behaviour","Colorectal Cancer","Behaviour Change"],"interventions":[{"type":"BEHAVIORAL","name":"PMT"},{"type":"BEHAVIORAL","name":"Non-contact Control"}],"sponsor":"Western University, Canada","sponsor_class":"OTHER","collaborators":[],"countries":["Canada"],"enrollment":152,"enrollment_type":"ESTIMATED","start_date":"2024-11-01","completion_date":"2025-03-01","first_posted":"2024-09-26","last_update":"2024-09-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06615648","reference_pmids":[],"brief_summary":"This study will examine the effectiveness of a 7-minute informational video using the threat and coping components of the Protection Motivation Theory (PMT) reduces alcohol intention and behaviour among young Canadian adults. Our aim is to determine whether perceived vulnerability, perceived severity, response efficacy and self-efficacy are associated with goal intentions to reduce drinking alcohol, and whether goals intentions to reduce alcohol drinking are associated with actual reductions in alcohol use among this population. Participants will be randomized to view either a specific PMT-video or a non-specific video on coffee and then complete questionnaires that relate to the PMT constructs. Intention and behaviour to drink alcohol will be compared between the two conditions over a 4-week period."},
{"id":"NCT07576309","registry":"ClinicalTrials.gov","slug":"repetitive-gon-blockade-for-menstrual-migraine-nct07576309","match":"direct","title":"Repetitive GON Blockade for Menstrual Migraine","official_title":"Perimenstrual Repetitive Greater Occipital Nerve Blockade for Menstrual Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Menstrual Migraine","Menstrually Related Migraine"],"keywords":["Menstrual Migraine","Greater Occipital Nerve Block","GON Blockade","Bupivacaine","Migraine Prophylaxis","Peripheral Neuromodulation","Perimenstrual Period"],"interventions":[{"type":"DRUG","name":"0.5% bupivacaine"},{"type":"OTHER","name":"Normal Saline"}],"sponsor":"Saglik Bilimleri Universitesi","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":48,"enrollment_type":"ACTUAL","start_date":"2024-10-19","completion_date":"2025-11-30","first_posted":"2026-05-08","last_update":"2026-05-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07576309","reference_pmids":["39948478"],"brief_summary":": The primary objective of this prospective, randomized, double-blind, placebo-controlled clinical trial is to evaluate whether repetitive bilateral greater occipital nerve (GON) blockade administered with a local anesthetic (0.5% bupivacaine) significantly reduces headache severity, attack duration, and the number of pain days in female patients with menstrual migraine compared to a placebo group (normal saline). Patients will receive injections twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation)."},
{"id":"NCT06648382","registry":"ClinicalTrials.gov","slug":"pilot-study-of-the-thriving-with-pmds-program-nct06648382","match":"direct","title":"Pilot Study of the 'Thriving With PMDs' Program","official_title":"Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders","acronym":null,"status":"RECRUITING","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Disorder","Premenstrual Dysphoric Disorder"],"keywords":["Psychotherapy","Premenstrual disorder","Premenstrual dysphoric disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Self-directed psychotherapy program for premenstrual disorders"}],"sponsor":"University of Regina","sponsor_class":"OTHER","collaborators":["International Association for Premenstrual Disorders"],"countries":["Canada"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2024-10-15","completion_date":"2025-10","first_posted":"2024-10-18","last_update":"2025-04-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06648382","reference_pmids":[],"brief_summary":"This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program."},
{"id":"NCT06621680","registry":"ClinicalTrials.gov","slug":"effect-of-connective-tissue-massage-on-premenstrual-syndrome-nct06621680","match":"direct","title":"Effect of Connective Tissue Massage on Premenstrual Syndrome","official_title":"Effect of Connective Tissue Massage on Premenstrual Syndrome","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Multivitamins"},{"type":"OTHER","name":"Connective tissue massage"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2024-10-10","completion_date":"2025-04-15","first_posted":"2024-10-01","last_update":"2024-10-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06621680","reference_pmids":[],"brief_summary":"This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome."},
{"id":"NCT06763809","registry":"ClinicalTrials.gov","slug":"a-randomized-placebo-controlled-study-to-evaluate-the-nct06763809","match":"direct","title":"A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome","official_title":"A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["PMS","Menstrual Cramp","Mood Change"],"keywords":["Fatigue","Bloating","Headaches/migraines","Constipation or diarrhea"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"PMS Capsule"},{"type":"DIETARY_SUPPLEMENT","name":"Capsule Placebo"},{"type":"DIETARY_SUPPLEMENT","name":"PMS Gummy"},{"type":"DIETARY_SUPPLEMENT","name":"Gummy Placebo"}],"sponsor":"Semaine Health","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":176,"enrollment_type":"ACTUAL","start_date":"2024-09-04","completion_date":"2024-12-12","first_posted":"2025-01-08","last_update":"2025-01-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06763809","reference_pmids":[],"brief_summary":"This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires."},
{"id":"NCT06610305","registry":"ClinicalTrials.gov","slug":"ovarian-hormone-withdrawal-anhedonia-and-reward-sensitivity-nct06610305","match":"direct","title":"Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression","official_title":"Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression: A Crossover Randomized Controlled Trial","acronym":"PEAR","status":"RECRUITING","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Major Depressive Disorder"],"keywords":["depression","hormone","premenstrual","estrogen","progesterone","perimenstrual"],"interventions":[{"type":"DRUG","name":"Transdermal estradiol"},{"type":"DRUG","name":"Progesterone"},{"type":"DRUG","name":"Transdermal placebo patch"},{"type":"DRUG","name":"placebo capsule"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":75,"enrollment_type":"ESTIMATED","start_date":"2024-09-02","completion_date":"2028-06-01","first_posted":"2024-09-24","last_update":"2025-10-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06610305","reference_pmids":[],"brief_summary":"The goal of this clinical trial is to learn how hormonal changes over the menstrual cycle affect mood symptoms in reproductive-aged women with depression that worsens during the premenstrual period. The main questions it aims to answer are: --How do fluctuations in estradiol and progesterone across the menstrual cycle affect the ability to experience pleasure and the neural sensitivity to reward in hormone-sensitive, depressed women? And consequently, how does stabilizing the luteal phase decline in estrogen and progesterone (using estradiol patches and progesterone pills) affect these changes? Participants will: * Receive hormones followed by placebo, or vice versa, for a total of four weeks across three menstrual cycles * Complete daily mood ratings * Collect home urine samples for hormone testing * Complete five biobehavioral testing sessions during which neural responses are recorded (via electroencephalography, or EEG) during an acute stress task and computer tasks"},
{"id":"NCT06461104","registry":"ClinicalTrials.gov","slug":"physical-activity-in-people-with-borderline-personality-nct06461104","match":"direct","title":"Physical Activity in People With Borderline Personality Disorder (PABORD)","official_title":"Physical Activity in People With Borderline Personality Disorder (PABORD): a Study Protocol for a Pilot Randomised Controlled Trial (RCT)","acronym":"PABORD","status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Borderline Personality Disorder"],"keywords":["Physical Activity","Borderline Personality Disorder","ESM","Females","Global Functioning","Accelerometer","Motivation","Premenstrual Syndrome","Outpatients"],"interventions":[{"type":"BEHAVIORAL","name":"Structured Physical Activity Programme"},{"type":"BEHAVIORAL","name":"Psychoeducational Programme"}],"sponsor":"IRCCS Centro San Giovanni di Dio Fatebenefratelli","sponsor_class":"OTHER","collaborators":[],"countries":["Italy"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2024-09-01","completion_date":"2025-04-01","first_posted":"2024-06-14","last_update":"2024-06-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06461104","reference_pmids":["39415283"],"brief_summary":"The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are: 1. Does a structured PA program reduce clinical symptoms in patients with BPD? 2. How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters? Participants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group). Researchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6)."},
{"id":"NCT05632315","registry":"ClinicalTrials.gov","slug":"pmt-for-mdro-decolonization-nct05632315","match":"direct","title":"PMT for MDRO Decolonization","official_title":"A Phase II Randomized Trial to Evaluate the Impact of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products on Recipient and Environmental Colonization With Multidrug-Resistant Organisms","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Multidrug Resistant Bacterial Infection","Enterobacteriaceae Infections","Pseudomonas Aeruginosa","VRE Infection","Methicillin-resistant Staphylococcus Aureus"],"keywords":[],"interventions":[{"type":"DRUG","name":"PMT"}],"sponsor":"University of Pennsylvania","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":32,"enrollment_type":"ACTUAL","start_date":"2024-08-19","completion_date":"2026-08-24","first_posted":"2022-11-30","last_update":"2026-09-24","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05632315","reference_pmids":[],"brief_summary":"This is a randomized, open label, comparative Phase II trial being conducted to determine whether fecal microbiota transplant using Penn Microbiome Therapy (PMT) products helps standard therapy eradicate antibiotic-resistant bacteria."},
{"id":"NCT07018479","registry":"ClinicalTrials.gov","slug":"effects-of-a-female-hormone-balance-supplement-on-nct07018479","match":"direct","title":"Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms","official_title":"Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["PMS","hormonal supplement","female hormone balance"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"FemmeBalance Supplement Group"}],"sponsor":"VINABAS FORMULATIONS SL","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":38,"enrollment_type":"ACTUAL","start_date":"2024-07-30","completion_date":"2025-01-20","first_posted":"2025-06-12","last_update":"2025-06-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07018479","reference_pmids":[],"brief_summary":"This virtual single-group study evaluates the effects of the FemmeBalance supplement on symptoms of premenstrual syndrome (PMS) over four menstrual cycles. The study involves daily intake of the supplement, regular questionnaires, and skin photo submissions for dermatological grading."},
{"id":"NCT07719686","registry":"ClinicalTrials.gov","slug":"effect-of-menstrual-cycle-phase-on-pain-perception-and-nct07719686","match":"related","title":"Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment","official_title":"Comparison of Pain Perception and Anxiety Levels During Non-Surgical Periodontal Treatment in Female Patients With Stage II and III Periodontitis at Different Phases of the Menstrual Cycle","acronym":"MAPP","status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Periodontitis"],"keywords":["Non-surgical periodontal treatment","Dental Anxiety","Pain Perception","Menstrual cycle"],"interventions":[{"type":"PROCEDURE","name":"Non Surgical Periodontal Treatment"}],"sponsor":"Karadeniz Technical University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":36,"enrollment_type":"ACTUAL","start_date":"2024-06-01","completion_date":"2025-05-01","first_posted":"2026-07-22","last_update":"2026-07-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07719686","reference_pmids":[],"brief_summary":"This study evaluates the effect of menstrual cycle phases on pain perception and dental anxiety during non-surgical periodontal therapy in premenopausal women with Stage II and III periodontitis. Pain and anxiety levels were assessed using VAS and DAS scales in perimenstrual and postmenstrual phases. Periodontal treatment outcomes were also recorded before and after therapy."},
{"id":"NCT07078708","registry":"ClinicalTrials.gov","slug":"effectiveness-of-non-hormonal-treatment-on-moderate-to-nct07078708","match":"direct","title":"Effectiveness of Non-hormonal Treatment on Moderate to Severe Premenstrual Syndrome","official_title":"Effectiveness of Non-hormonal Treatment on Moderate to Severe Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":["Calcium","Vitamin-D","Premenstrual Symptoms"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"vitamin D (cholecalciferol) supplementation"},{"type":"OTHER","name":"Placebo"}],"sponsor":"Haleema Sadia","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2024-06-01","completion_date":"2024-11-30","first_posted":"2025-07-22","last_update":"2025-07-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07078708","reference_pmids":[],"brief_summary":"A double-blind, randomised, placebo-controlled, parallel trial was conducted involving 100 females aged 18-40, all of whom presented with premenstrual syndrome at the Department of Gynecology and Obstetrics, Avicenna Medical College Hospital, Lahore, Pakistan. Participants were randomly assigned to two groups of equal size: One group received vitamin D supplementation at a dose of 50,000 IU every two weeks along with a daily intake of 1,000 mg of calcium, whereas the comparison group was administered a placebo under the same conditions for 12 weeks. All the participants were examined on premenstrual syndrome with the Premenstrual Symptoms Screening Tool-Adolescent (PSST-A) questionnaire"},
{"id":"NCT07037667","registry":"ClinicalTrials.gov","slug":"new-management-of-pms-anxiety-nct07037667","match":"direct","title":"New Management of PMS Anxiety","official_title":"Effect of Pilates Exercises in Management of Premenstrual Anxiety","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Anxiety"],"keywords":["Premenstrual","Anxiety","Pilates exercises"],"interventions":[{"type":"OTHER","name":"Pilates exercises"},{"type":"OTHER","name":"Dietary recommendations"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"2024-05-22","completion_date":"2025-02-04","first_posted":"2025-06-25","last_update":"2025-06-25","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07037667","reference_pmids":[],"brief_summary":"The goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is : Do Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary recommendations as healthy snacks rich in magnesium and vitamin B-6 to see if Pilates exercises have an effect on premenstrual anxiety. Participants will : Do Pilates exercises two times per week for 12 weeks."},
{"id":"NCT06991413","registry":"ClinicalTrials.gov","slug":"impact-of-an-app-on-the-quality-of-life-and-symptoms-in-nct06991413","match":"direct","title":"Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome","official_title":"Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Premenstrual Syndrome-PMS"],"keywords":["Digital Therapeutics","Premenstrual syndrome (PMS)"],"interventions":[{"type":"DEVICE","name":"PMS App"}],"sponsor":"Endo Health GmbH","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Germany"],"enrollment":175,"enrollment_type":"ACTUAL","start_date":"2024-05-16","completion_date":"2024-10-25","first_posted":"2025-05-28","last_update":"2025-05-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06991413","reference_pmids":[],"brief_summary":"This pilot study explored the effectiveness and acceptance of a digital app for the self-management of PMS. A total of 175 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on PMS-specific symptoms and broader health aspects such as fatigue and emotional well-being. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care."},
{"id":"NCT06370429","registry":"ClinicalTrials.gov","slug":"effect-of-online-exercises-for-premenstrual-syndrome-on-nct06370429","match":"direct","title":"Effect of Online Exercises for Premenstrual Syndrome on Couple's Stress and Family Function","official_title":"The Effect of Progressive Relaxation Exercises Performed Online by Women With Premenstrual Syndrome on the Stress Level and Family Functionality of Women and Their Spouses","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Exercises","Stress Level","Family Characteristics"],"keywords":["Premenstrual Syndrome","Progressive Relaxation","Stress Level","Family Functionality"],"interventions":[{"type":"OTHER","name":"Progressive Relaxation Exercises, randomized pretest-posttest"}],"sponsor":"Suleyman Demirel University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2024-05-15","completion_date":"2024-12-30","first_posted":"2024-04-17","last_update":"2024-05-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06370429","reference_pmids":[],"brief_summary":"Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media. 3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants. Criteria for inclusion in the study: * Being married and living with his wife * Being between the ages of 18-45, * The woman's ability to use a mobile phone and/or computer to receive online * The woman and her husband must be literate * The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome. Exclusion criteria from the study: 1. He or his spouse fills out the research survey forms incompletely, 2. Pregnancy occurs, 3. Receiving breathing exercise consultancy from another consultant during the study period Data Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached."},
{"id":"NCT06705660","registry":"ClinicalTrials.gov","slug":"effect-of-web-based-life-style-training-and-relaxation-nct06705660","match":"direct","title":"Effect of Web-Based Life Style Training and Relaxation Training in Women With Premenstrual Syndrome","official_title":"Investigation of the Effects of WEB-based Lifestyle Training and Progressive Relaxation Training in Women With Premenstrual Syndrome: 4-Week Follow-up Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Lifestyle","Relaxation","Women"],"interventions":[{"type":"OTHER","name":"WEB-based progressive relaxation training"},{"type":"OTHER","name":"The WEB-based lifestyle interventions"}],"sponsor":"Aysenur KARAKUS","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":66,"enrollment_type":"ACTUAL","start_date":"2024-05-05","completion_date":"2025-05-30","first_posted":"2024-11-26","last_update":"2025-09-11","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06705660","reference_pmids":[],"brief_summary":"The aim of this study is to investigate the effectiveness of web-based lifestyle education and progressive relaxation training provided to women with PMS. During menstruation, an important indicator of reproductive health, women encounter various problems. One of these problems is premenstrual syndrome (PMS). PMS is characterized by its occurrence in 30-40% of women of reproductive age, beginning in the late luteal phase of their menstrual cycle, and presenting with a series of physical, psychological, emotional, behavioral, and social symptoms that end with menstruation. Common symptoms of PMS include changes in appetite, irritability, depression, anxiety, difficulty concentrating, headaches, weight gain, constipation, fatigue, abdominal and lower back pain, breast swelling and tenderness, and mood swings. These symptoms negatively affect the quality of life and participation in social and family activities of women with PMS. Moreover, it leads to reduced productivity in the workforce, lower quality of work life, economic losses, and increased accident potential. Additionally, it has been observed to negatively impact young women's self-esteem, school attendance if they are students, academic success, and willingness to engage in hobbies, thereby affecting their participation in meaningful and purposeful activities-referred to as occupations. Managing lifestyle changes and controlling symptoms in PMS is only possible through behavior change. Recent studies have focused on web-based lifestyle interventions and progressive relaxation training (PRT) to promote behavior change in PMS. The accessibility, ease of use, cost/time efficiency, centralization of user health data, and the ability to update remotely make web-based applications a preferred option in health interventions. In this study, women with PMS will be divided into three groups. The first group will receive web-based lifestyle interventions, the second group will receive web-based PRT, and the third group will serve as a control group without any education. Web-based lifestyle interventions and PRT will be provided by tracking the menstrual cycles of the women. Both interventions will be delivered over the course of two menstrual cycles. A follow-up assessment will be conducted one month after the completion of the trainings (4 weeks later, during the next cycle). Assessments will be planned for both before the intervention (baseline assessment) and after the intervention (8 weeks later). The women's sociodemographic and clinical characteristics related to menstruation will be assessed with the Sociodemographic and Clinical Information Form, their type and severity of premenstrual symptoms with the Premenstrual Syndrome Scale, their anxiety and stress levels with the Hospital Anxiety and Stress Scale, their quality of life with the Nottingham Health Profile, their occupational performance and participation with the Canadian Occupational Performance Measure, and their occupational satisfaction with the Occupational Balance Questionnaire."},
{"id":"NCT06365515","registry":"ClinicalTrials.gov","slug":"dopamine-reward-learning-and-sex-hormones-nct06365515","match":"related","title":"Dopamine, Reward Learning and Sex Hormones","official_title":"Dopamine and Reward Learning Across Hormonal Transition Phases","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Hormonal Changes","Menstrual Cycle"],"keywords":["dopamine","fMRI","energy homeostasis","mood homeostasis","sex hormones","motivation","menstrual cycle"],"interventions":[{"type":"DRUG","name":"Levodopa administration"},{"type":"DRUG","name":"Placebo administration"}],"sponsor":"University Hospital Tuebingen","sponsor_class":"OTHER","collaborators":["German Research Foundation","Uppsala University"],"countries":["Germany"],"enrollment":90,"enrollment_type":"ESTIMATED","start_date":"2024-05","completion_date":"2025-12","first_posted":"2024-04-15","last_update":"2024-05-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06365515","reference_pmids":[],"brief_summary":"Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, the investigators aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis. To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, the effects of hormonal status on metabolic indices will be tested, and its effects on mood fluctuations in a period of a month. The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. The investigator has exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explores if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase."},
{"id":"NCT06382090","registry":"ClinicalTrials.gov","slug":"premenstrual-syndrome-and-laughter-yoga-nct06382090","match":"direct","title":"Premenstrual Syndrome and Laughter Yoga","official_title":"The Effect of Laughter Yoga on Premenstrual Syndrome in Adolescents","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Laughter"],"keywords":["Laughter Yoga","Premenstrual Syndrome","Adolescent"],"interventions":[{"type":"OTHER","name":"Laughter yoga"}],"sponsor":"Pamukkale University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":68,"enrollment_type":"ESTIMATED","start_date":"2024-04-26","completion_date":"2025-05-24","first_posted":"2024-04-24","last_update":"2024-04-24","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06382090","reference_pmids":[],"brief_summary":"In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined."},
{"id":"NCT06296043","registry":"ClinicalTrials.gov","slug":"the-effect-of-su-jok-application-and-progressive-muscle-nct06296043","match":"direct","title":"The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome","official_title":"The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Nursing","Su-Jok","Progressive muscle relaxation exercise"],"interventions":[{"type":"PROCEDURE","name":"Progressive Muscle Relaxation Exercise Group"},{"type":"PROCEDURE","name":"Su-Jok Intervention"}],"sponsor":"Saglik Bilimleri Universitesi","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":135,"enrollment_type":"ESTIMATED","start_date":"2024-04-10","completion_date":"2024-08-15","first_posted":"2024-03-06","last_update":"2024-06-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06296043","reference_pmids":[],"brief_summary":"The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome."},
{"id":"NCT06191289","registry":"ClinicalTrials.gov","slug":"neurocognitive-mechanisms-of-perimenstrual-estrogen-effects-nct06191289","match":"direct","title":"Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality","official_title":"Clarifying the Endocrinology of Acute Risk 4 (CLEAR-4): Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality","acronym":"CLEAR-4","status":"TERMINATED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Suicide"],"keywords":["MENSTRUAL CYCLE","HORMONES","ESTROGEN","REWARD","EXECUTIVE FUNCTION"],"interventions":[{"type":"DRUG","name":"Transdermal Estradiol"},{"type":"OTHER","name":"Placebo"}],"sponsor":"University of Illinois at Chicago","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":11,"enrollment_type":"ACTUAL","start_date":"2024-03-16","completion_date":"2024-12-01","first_posted":"2024-01-05","last_update":"2025-10-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06191289","reference_pmids":[],"brief_summary":"This within-person, crossover, 2-condition, placebo-controlled study compares the impact of two perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) perimenstrual administration of estradiol and (2) natural perimenstrual withdrawal from estradiol during placebo."},
{"id":"NCT06204016","registry":"ClinicalTrials.gov","slug":"estradiol-and-stress-reactivity-in-women-nct06204016","match":"related","title":"Estradiol and Stress Reactivity in Women","official_title":"Associations of Estradiol and Stress Reactivity in Pre- and Postmenopausal Women","acronym":null,"status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Stress vs. Control","Estradiol vs. Placebo"],"keywords":["stress reactivity","mood homeostasis","neuroimaging (fMRI)","menopause","menstrual cycle","sex hormones","women's mental health","estradiol"],"interventions":[{"type":"DRUG","name":"Estradiol Valerate"},{"type":"DRUG","name":"Placebo"}],"sponsor":"International Research Training Group 2804","sponsor_class":"OTHER","collaborators":["University Hospital Tuebingen","German Research Foundation","Uppsala University"],"countries":["Germany"],"enrollment":74,"enrollment_type":"ESTIMATED","start_date":"2024-03-07","completion_date":"2025-12","first_posted":"2024-01-12","last_update":"2024-03-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06204016","reference_pmids":[],"brief_summary":"Stress reactivity and prevalence of stress related diseases differ between pre- and postmenopausal women. Thus, hormonal fluctuations may present a general vulnerability factor for stress-related diseases. Especially, the gonadal hormone estradiol (E2) seems to modulate the activity of stress related brain areas. The hippocampus and prefrontal areas control the amygdala's response to stress, and E2 may directly modulate the activity, connectivity and structure of these areas. In premenopausal women E2 seems to reduce stress reactivity. However, in postmenopausal women, who no longer produce E2 from the ovaries, E2 seem to increase stress reactivity. With the proposed study the investigators want to directly test E2's modulating effects (disentangled from other gonadal hormones) on stress reactivity of premenopausal women during their early follicular phase, and postmenopausal women by subjecting both groups of women to a psychosocial stress task in a neuroimaging environment."},
{"id":"NCT06835062","registry":"ClinicalTrials.gov","slug":"clinical-pilates-impact-on-fitness-symptoms-kinesiophobia-in-nct06835062","match":"direct","title":"Clinical Pilates' Impact on Fitness, Symptoms & Kinesiophobia in PMS","official_title":"The Effects of Clinical Pilates on Physical Fitness Parameters, Symptom Severity, and Kinesiophobia in Women With Premenstrual Syndrome.","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Pilates Exercise"],"keywords":["Premenstrual Syndrome","Physical Fitness","Kinesiophobia","Clinic Pilates"],"interventions":[{"type":"BEHAVIORAL","name":"Recommendations for Enhancing General Well-Being"},{"type":"OTHER","name":"Clinical Pilates"}],"sponsor":"Atlas University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2024-03-04","completion_date":"2025-02-01","first_posted":"2025-02-19","last_update":"2025-02-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06835062","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is characterized by a series of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle, affecting approximately 30% of women and resolving with menstruation. These symptoms impact daily activities, interpersonal relationships, social engagements, work efficiency, and educational productivity. PMS manifests with physical symptoms such as breast swelling and tenderness, fatigue, headaches, and weight gain, as well as psychological and emotional symptoms such as mood disorders, irritability, and stress. Symptoms typically subside with the onset of menstruation. There is no single accepted treatment for PMS. Due to conflicting findings in studies, various treatment methods are used, including lifestyle modifications, education, stress management techniques (such as massage, reflexology, and yoga), exercise, or medical support. Regular exercise is known to improve overall well-being. It prevents the decrease in endorphin secretion during the luteal phase of the menstrual cycle and has a positive impact on PMS symptoms, particularly mood disorders, fluid retention, and breast tenderness. Pilates-based exercise training is an approach that enhances muscle stability through effective, controlled movements while strengthening muscle groups associated with pain. Clinical Pilates-based exercise training is considered a preferable method for PMS management, as it is believed to improve functional capacity, pain management, mood disorders, endurance, flexibility, symptom severity, and fear of movement in individuals with PMS. Due to the limited number of studies in the literature on PMS, our study aims to investigate the effects of a clinical Pilates-based exercise program on functional fitness parameters, symptom severity, and kinesiophobia."},
{"id":"NCT06535698","registry":"ClinicalTrials.gov","slug":"evaluating-the-effect-of-a-supplement-on-symptoms-of-nct06535698","match":"related","title":"Evaluating the Effect of a Supplement on Symptoms of Hormonal Imbalance.","official_title":"A Single-Group Clinical Trial to Evaluate the Effect of an Oral Supplement to Provide Relief From Symptoms of Hormonal Imbalance.","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Women's Health"],"keywords":["Hormonal Balance Support","Menstrual Cycle","Mood Swings"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Perelel Health Hormonal Balance Support"}],"sponsor":"Perelel Inc.","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":35,"enrollment_type":"ACTUAL","start_date":"2024-02-19","completion_date":"2024-06-10","first_posted":"2024-08-02","last_update":"2024-08-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06535698","reference_pmids":[],"brief_summary":"This is a virtual single-group trial lasting 12 weeks to evaluate the effects of Perelel Health's hormonal balance support on symptoms of hormonal imbalance and overall menstrual health."},
{"id":"NCT06530368","registry":"ClinicalTrials.gov","slug":"effect-of-a-calisthenic-exercises-on-premenstrual-symptoms-nct06530368","match":"direct","title":"Effect of a Calisthenic Exercises on Premenstrual Symptoms","official_title":"Investigation of the Effect of a Calisthenic Home Exercise Program on Premenstrual Symptoms, Pain and Sleep Quality in Young Women","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Menstrual Pain"],"keywords":[],"interventions":[{"type":"OTHER","name":"Calisthenic home exercise programs"}],"sponsor":"Halic University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":30,"enrollment_type":"ACTUAL","start_date":"2024-02-15","completion_date":"2024-05-15","first_posted":"2024-07-31","last_update":"2024-07-31","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06530368","reference_pmids":["22588748","29855308","32522750"],"brief_summary":"The aim of this study is to examine the effects of an eight-week calisthenic home exercise program on premenstrual symptoms, pain and sleep quality in young women."},
{"id":"NCT07217418","registry":"ClinicalTrials.gov","slug":"music-therapy-and-its-effects-on-premenstrual-syndrome-pms-nct07217418","match":"direct","title":"Music Therapy and Its Effects on Premenstrual Syndrome (PMS)","official_title":"Music Therapy and Its Effects on Premenstrual Syndrome (PMS)","acronym":"PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Menstrual Symptoms"],"keywords":["Music therapy","PMS","Premenstrual syndrome","Music Based Intervention"],"interventions":[{"type":"BEHAVIORAL","name":"Music Listening Group (LG)"},{"type":"BEHAVIORAL","name":"Participant-Selected Songs for the Interactive Singing Intervention Group (SG)"},{"type":"BEHAVIORAL","name":"Participant-Selected Songs for the Interactive Instrumental Playing Group (PG)"}],"sponsor":"West Chester University of Pennsylvania","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":20,"enrollment_type":"ACTUAL","start_date":"2024-02-01","completion_date":"2024-06-01","first_posted":"2025-10-16","last_update":"2025-10-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07217418","reference_pmids":["29255434","31086543"],"brief_summary":"The purpose of the research is to explore the effects of music therapy on premenstrual syndrome and its symptoms. The goal of this study is to answer the following research questions: 1. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the physiological responses (EMG, skin conductance, and heart rate) of college students with PMS? 2. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the brain wave (EEG) of college students with PMS? 3. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the anxiety level of college students with PMS? 4. Will the passive music listening group and music therapy group (singing and instrumental playing) have a different effect on the pain perception of college students with PMS? 5. How do college students with PMS respond after listening to music, singing, and instrumental playing? Participants were randomly assigned to one of three groups: a passive music-listening group, an active singing group, or an active instrumental-playing group. Physiological responses were collected before, during, and after the intervention. Participants who volunteered completed a written survey following the intervention."},
{"id":"NCT06289764","registry":"ClinicalTrials.gov","slug":"the-effect-of-aromatherapy-application-with-bergamot-and-nct06289764","match":"direct","title":"The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS","official_title":"The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on Premenstrual Syndrome and Menstrual Symptoms","acronym":"Aromatherapy","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"HEALTH_SERVICES_RESEARCH","conditions":["Premenstrual Syndrome-PMS"],"keywords":["Aromatherapy","Premenstrual syndrome","Menstrual symptom"],"interventions":[{"type":"OTHER","name":"Bergamot Essential Oil"},{"type":"OTHER","name":"Grapefruit Essential Oil"},{"type":"OTHER","name":"Sweet almond oil"}],"sponsor":"Esra ÖZER","sponsor_class":"OTHER","collaborators":["KTO Karatay University"],"countries":["Turkey (Türkiye)"],"enrollment":90,"enrollment_type":"ACTUAL","start_date":"2024-02-01","completion_date":"2024-06-24","first_posted":"2024-03-04","last_update":"2024-10-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06289764","reference_pmids":["40312670"],"brief_summary":"Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being. Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints. Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms."},
{"id":"NCT06208670","registry":"ClinicalTrials.gov","slug":"progressive-muscle-relaxation-exercises-on-premenstrual-nct06208670","match":"direct","title":"Progressive Muscle Relaxation Exercises on Premenstrual Syndrome","official_title":"The Effect of Progressive Muscle Relaxation Exercises Given to Women Experiencing Premenstrual Syndrome on Premenstrual Syndrome Symptoms and Tendency to Violence","acronym":"PMS","status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome Symptoms","Tendency to Violence","Progressive Muscle Relaxation Exercises"],"interventions":[{"type":"BEHAVIORAL","name":"Progressive muscle relaxation exercises"},{"type":"BEHAVIORAL","name":"Violent tendency Scale"}],"sponsor":"Siirt University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":100,"enrollment_type":"ESTIMATED","start_date":"2024-01-15","completion_date":"2024-08-15","first_posted":"2024-01-17","last_update":"2024-01-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06208670","reference_pmids":["40221724"],"brief_summary":"Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence. Materials and Methods: The research was planned as an experimental study with a pretest-posttest control group, with female patients coming for examination at Siirt Training and Research Hospital Gynecology Polyclinics between December 2023 and August 2024. \"Personal Information Form, Premenstrual Syndrome Scale and Violence Tendency Scale\" were used to collect data in the study. Percentage distributions and t-test in independent groups were used to evaluate the data."},
{"id":"NCT06206460","registry":"ClinicalTrials.gov","slug":"follow-up-assessment-of-a-trial-of-open-label-placebos-for-nct06206460","match":"direct","title":"Follow-up Assessment of a Trial of Open-label Placebos for Women With Premenstrual Syndrome","official_title":"Follow-up Assessment of the Randomized Controlled Trial: Open-label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Open-label Placebo","RCT follow up"],"interventions":[{"type":"OTHER","name":"Online Assessment"}],"sponsor":"University Hospital, Basel, Switzerland","sponsor_class":"OTHER","collaborators":[],"countries":["Switzerland"],"enrollment":66,"enrollment_type":"ACTUAL","start_date":"2024-01-04","completion_date":"2024-07-03","first_posted":"2024-01-16","last_update":"2024-08-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06206460","reference_pmids":[],"brief_summary":"With the proposed study, the investigators aim to evaluate the long-term efficacy of the open-label placebo (OLP) intervention in premenstrual syndrome (PMS) and to contribute to a broader understanding of how OLPs work. It is planned to survey participants of the intervention groups (OLP+ and OLP-) regarding symptom intensity and impairment due to PMS after the conclusion of our randomized controlled trial (RCT) and intervention provision. Additionally, it will be examined if there is a difference between the OLP group with and without a treatment rationale (OPL+ vs. OLP-) across time. More precisely, it will be investigated whether participants of the intervention groups with and without treatment rationale experience any long-term improvement."},
{"id":"NCT06130371","registry":"ClinicalTrials.gov","slug":"stress-inflammation-and-neuroimaging-in-major-depressive-nct06130371","match":"direct","title":"Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder","official_title":"Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder","acronym":null,"status":"RECRUITING","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["MDD","PMDD"],"keywords":["MDD","PMDD","Stress","Inflammation","Cytokines","fMRI","MIST"],"interventions":[],"sponsor":"University Hospital Tuebingen","sponsor_class":"OTHER","collaborators":[],"countries":["Germany"],"enrollment":75,"enrollment_type":"ESTIMATED","start_date":"2024-01-04","completion_date":"2026-07","first_posted":"2023-11-14","last_update":"2026-04-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06130371","reference_pmids":[],"brief_summary":"Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women. Stress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity. There are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study."},
{"id":"NCT06201702","registry":"ClinicalTrials.gov","slug":"effect-of-pomegranate-supplementation-on-symptom-severity-in-nct06201702","match":"direct","title":"Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome","official_title":"Investigation of the Effect of Pomegranate Supplementation on Symptom Severity in Women With Premenstrual Syndrome: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Pomegranate","Premenstrual Syndrome"],"keywords":["premenstrual syndrome","pomegranate","premenstrual symptom","PMS"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"pomegranate extract"}],"sponsor":"Sakarya University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"2024-01-02","completion_date":"2024-06-03","first_posted":"2024-01-11","last_update":"2024-06-04","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06201702","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is a common disorder among women of reproductive age. About 40% of women report problems with their menstrual cycle. Pomegranate supplementation is one of the practices that may reduce symptoms of premenstrual syndrome (PMS). This study was planned to determine the effect of pomegranate supplementation on the severity of premenstrual syndrome (PMS) symptoms. In the study to be conducted in 2023 with women diagnosed with PMS living in Sakarya province, the individuals to be included in the study will be determined by snowball sampling method and those who meet the inclusion criteria will participate in the study. The researchers will divide the participants into control and intervention groups by using NCSS (statistical software) in a 1:1 ratio using a simple block randomization approach based on CONSORT guidelines. The individuals in the control group will first be administered the PMSÖ (Premenstrual Syndrome Rating Scale) and no intervention will be made. Participants in the intervention group will be informed about 3 mL pomegranate supplementation 13,14 three times a day for 10 days during 2 menstrual cycles (between 7 days before and 3 days after the estimated onset of menstruation). The test will be repeated at the end of the 2nd month post-intervention. Normality of continuous data will be assessed by Kolmogorov-Smirnov test. Data will be expressed as mean ± SD or median and interquartile range (IQR) as appropriate. Variables will be compared between the two intervention and placebo groups using Student's T-test (parametric data) or Mann-Whitney (non-parametric data) or chi-square tests (for qualitative indices). Analyses of changes from pre-intervention to post-intervention within the identified groups will be performed using the Dependent Two Sample t Test (normally distributed parameters) or Wilcoxon signed rank test (non-normally distributed and categorical parameters). All statistical calculations will be performed with SPSS software version 18."},
{"id":"NCT07063472","registry":"ClinicalTrials.gov","slug":"kinesio-taping-vs-tele-pilates-for-pms-nct07063472","match":"direct","title":"Kinesio Taping vs Tele-Pilates for PMS","official_title":"Effect of Kinesio Taping Versus Tele-Pilates Intervention on Pre-menstrual Syndrome","acronym":"premensterual","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Disorder"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Tele- pilates"},{"type":"DEVICE","name":"Kinesio taping application for the KT group"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":90,"enrollment_type":"ACTUAL","start_date":"2024-01-01","completion_date":"2025-03-01","first_posted":"2025-07-14","last_update":"2025-07-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07063472","reference_pmids":[],"brief_summary":"Premenstrual Syndrome (PMS) has a wide variety of signs and symptoms, including physical, psychological, and behavioral symptoms severe enough to disrupt daily activities. Objective: The study aimed to compare the effectiveness of a Tele-Pilates intervention and Kinesio Taping in managing symptoms of premenstrual syndrome (PMS)."},
{"id":"ISRCTN12142665","registry":"ISRCTN","slug":"an-innovative-nutraceutical-formulation-for-appetite-control-isrctn12142665","match":"direct","title":"An innovative nutraceutical formulation for appetite control and premenstrual syndrome symptom management","official_title":"Randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy of a nutraceutical containing Cinchona bark, Chicory root, Gentian root, Griffonia simplicifolia and Vitex agnus-castus in women with premenstrual syndrome","acronym":"AGRIGENINA","status":"NO_LONGER_RECRUITING","phases":[],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual syndrome in women of reproductive age"],"keywords":["Urological and Genital Diseases"],"interventions":[{"type":"Supplement","name":null}],"sponsor":"NGN Healthcare—New Generation Nutraceuticals s.r.l.","sponsor_class":null,"collaborators":[],"countries":["Italy"],"enrollment":120,"enrollment_type":"ACTUAL","start_date":"2024-01-01","completion_date":"2024-08-31","first_posted":"2026-03-25","last_update":null,"has_results":false,"results_url":null,"url":"https://www.isrctn.com/ISRCTN12142665","reference_pmids":[],"brief_summary":null},
{"id":"NCT05599594","registry":"ClinicalTrials.gov","slug":"premenstrual-symptoms-and-aromatherapy-nct05599594","match":"direct","title":"Premenstrual Symptoms and Aromatherapy","official_title":"Effect of Neroli and Lemongrass Oils With Premenstrual Symptoms and Effect on Quality of Life: Randomized Controlled Research","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Aromatherapy"],"keywords":["Aromatherapy","Premenstrual symptom","Quality of life"],"interventions":[{"type":"OTHER","name":"Aromatherapy"}],"sponsor":"KTO Karatay University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":120,"enrollment_type":"ESTIMATED","start_date":"2023-12-15","completion_date":"2024-07-30","first_posted":"2022-10-31","last_update":"2023-10-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05599594","reference_pmids":[],"brief_summary":"Aromatherapy is the science of using high concentrated essential oils or essences with distilled high concentration of plants to take advantage of therapeutic properties '' . Essential oils or essences are obtained from various parts of plants (root, leaf, flower, shell, fruit) and therapeutically used for physical and psychological favors. The aromatherapine is a noninvasive process and the convenience of use allows the widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These are topical (tap, compressed or bath), internal (mouthwash, vaginal or anal wick), mouth (with capsules or honey, alcohol or diluent) and inhalation (inhalation directly or indirectly, steam or vapor ) is the way . Volatile oils that can be applied in various means can reach the neocortex part of the brain directly with the links to the hypothalamus from the limbic system. As a result of the impact of aromatic oils on the central nervous system, relief, sedation or stimulating effects are formed and the energy blockage in the body is broken, due to the information stream reaching the brain with the warning of the central nervous system and the resulting energy is exposed. The improvement process is supported by its exposed energy stream in a balanced way of the relevant organs, and the state of physical and spiritual goodness is emerged. Aromatherapy is also used in the field of women's health as well as many health areas."},
{"id":"NCT06117215","registry":"ClinicalTrials.gov","slug":"prevalence-of-premenstrual-syndrome-in-women-of-reproductive-nct06117215","match":"direct","title":"Prevalence of Premenstrual Syndrome in Women of Reproductive Age","official_title":"Prevalence of Premenstrual Syndrome in Women of Reproductive Age","acronym":"Sd-Premens","status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","women reproductive age","prevalence"],"interventions":[{"type":"OTHER","name":"Data collection"}],"sponsor":"Université de Reims Champagne-Ardenne","sponsor_class":"OTHER","collaborators":[],"countries":["France"],"enrollment":2000,"enrollment_type":"ESTIMATED","start_date":"2023-12-01","completion_date":"2024-05-01","first_posted":"2023-11-03","last_update":"2023-11-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06117215","reference_pmids":[],"brief_summary":"The menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome. Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. This definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women. The impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. Therefore, few women report the existence of these disorders to healthcare professionals. As the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed. This pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome."},
{"id":"NCT05796869","registry":"ClinicalTrials.gov","slug":"the-effect-of-laughter-therapy-on-the-food-craving-nct05796869","match":"direct","title":"The Effect of Laughter Therapy On The Food Craving","official_title":"The Effect of Laughter Therapy On The Food Craving in Young Women With Premenstrual Syndrome","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["PMS","LAUGHTER","Food Habits"],"keywords":["PMS","Laughter Therapy","Young women","Food Craving"],"interventions":[{"type":"BEHAVIORAL","name":"Assigned Interventions"}],"sponsor":"Sinop University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":90,"enrollment_type":"ESTIMATED","start_date":"2023-11-20","completion_date":"2024-01-30","first_posted":"2023-04-04","last_update":"2023-12-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05796869","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is characterized by physical, emotional, and behavioral symptoms in the luteal phase that significantly disrupt women's daily lives, including work and personal activities, and resolve spontaneously within a few days of the onset of menstruation. The premenstrual syndrome causes emotional eating, excessive consumption of certain foods, and increased appetite. These unhealthy eating patterns in eating behavior affect health negatively. Women with PMS have an increased appetite and food cravings. It has been stated that the increase in appetite and food cravings are reduced by laughter therapy. Thus, the laughter therapy method, which has no side effects in PMS and negative eating behaviors, can be used and recommended or applied by health professionals."},
{"id":"NCT06585475","registry":"ClinicalTrials.gov","slug":"investigation-of-the-effectiveness-of-structured-education-nct06585475","match":"direct","title":"Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map","official_title":"The Effectiveness of Structured Training According to the Premenstrual Syndrome Symptom Map","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndromes","Education","Menstrual Cycle Disorder"],"keywords":["life satisfaction","pain","depression","stress","anxiety"],"interventions":[{"type":"BEHAVIORAL","name":"Structured training according to premenstrual syndrome symptom map"}],"sponsor":"Sakarya University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":101,"enrollment_type":"ACTUAL","start_date":"2023-11-01","completion_date":"2024-08-05","first_posted":"2024-09-05","last_update":"2024-09-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06585475","reference_pmids":["42742795"],"brief_summary":"In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test."},
{"id":"NCT06557070","registry":"ClinicalTrials.gov","slug":"the-effect-of-emotional-freedom-technique-on-premenstrual-nct06557070","match":"direct","title":"The Effect of Emotional Freedom Technique on Premenstrual Syndrome","official_title":"The Effect of Emotional Freedom Technique on Premenstrual Syndrome, Menstrual Symptom and Life Quality of Nursing Students: A Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome","Emotional Freedom Technique","Nursing Caries"],"keywords":["Premenstrual Syndrome","menstrual symptom","life quality","emotional freedom technique","Nursing Care"],"interventions":[{"type":"OTHER","name":"The Emotional Freedom Technique"}],"sponsor":"Dokuz Eylul University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":70,"enrollment_type":"ACTUAL","start_date":"2023-11-01","completion_date":"2025-01-17","first_posted":"2024-08-16","last_update":"2025-09-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06557070","reference_pmids":["42319509"],"brief_summary":"Introduction: Premenstrual Syndrome (PMS) is a condition that occurs in the luteal phase of the menstrual cycle and affects women's lives physically, psychologically and behaviorally, starting approximately five days before menstruation and decreasing spontaneously a few days later. Purpose: This research is planned to examine the effect of the Emotional Freedom Technique on the experience of premenstrual syndrome and menstrual symptoms and the quality of life of nursing students with premenstrual syndrome. Method: The research will be conducted with first, second, third and fourth year female students studying at Dokuz Eylül University Faculty of Nursing. Diagnostic information form, premenstrual syndrome scale, menstruation symptom scale, SF-12 quality of life scale and subjective danger units will be collected via Google form. SUD Scale will be applied. The research is designed with experimental and control groups, and it is found that a total of 70 female students are needed, 35 in the experimental group and 35 in the control group. PMSS analysis will be performed and students who score over 132 points and meet the inclusion criteria will be numbered in the order of filling out the survey, and randomization will be done using the \"Random Sequence Generator\" through www.random.org, which provides computer-assisted randomization, and experimental and control groups will be created. Simple randomization will be applied to keep the control and experimental groups equal. To ensure blinding in the study, randomization will be carried out by someone other than the researchers. A total of 8 sessions of Emotional Freedom Technique (EFT) will be applied to the experimental group, once a week. No application other than the scales will planned for the control group."},
{"id":"NCT06105567","registry":"ClinicalTrials.gov","slug":"the-effect-of-education-given-according-to-the-health-nct06105567","match":"direct","title":"The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress","official_title":"The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress","acronym":"Premenstrual","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome","Emotional Disorder","Perceived Stress"],"keywords":["premenstrual syndrome","emotional eating","health promotion model"],"interventions":[{"type":"BEHAVIORAL","name":"Training given according to the health promotion model by applying the Philips 66 technique"}],"sponsor":"Kafkas University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":86,"enrollment_type":"ACTUAL","start_date":"2023-10-30","completion_date":"2024-10-07","first_posted":"2023-10-27","last_update":"2025-02-10","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06105567","reference_pmids":["42121133"],"brief_summary":"Nurses have important duties in this regard due to their roles such as health education, health protection, development and consultancy. In this study, it is thought that the training given according to the health promotion model will both create a resource for nurses and contribute to the literature with the results obtained by applying this training to people experiencing PMS.The research will be conducted as a pretest-posttest randomized controlled study. H1: Education given according to the health promotion model has an effect on premenstrual symptoms, emotional eating behavior and perceived stress. H0: Education given according to the health promotion model has no effect on premenstrual symptoms, emotional eating behavior and perceived stress. The total number of students in the research population is 330.In the G\\*Power 3.1.9.7 program, for the effect size t test, d = 0.94, alpha (α) = 0.05, and power (1-β) = 0.95, and the minimum total sample number was determined as 52, experimental group: 26, control group: 26. . However, taking into account the losses in the study, a total of 60 people will be included in the study. (experiment:30, control:30). The first group will be divided into the group trained according to the health promotion model using the Philips 66 technique, and the second group will be divided into the control group."},
{"id":"NCT06176313","registry":"ClinicalTrials.gov","slug":"effects-of-training-given-to-cope-with-premenstrual-syndrome-nct06176313","match":"direct","title":"Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms","official_title":"Investigation of the Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms","acronym":"MANDALA","status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["premenstrual syndrome","mandala","education","premenstrual symptoms"],"interventions":[{"type":"OTHER","name":"Mandala Group"},{"type":"OTHER","name":"Coping with Premenstrual Symptoms Education Group"},{"type":"OTHER","name":"Control Group"}],"sponsor":"Eskisehir Osmangazi University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":90,"enrollment_type":"ESTIMATED","start_date":"2023-10-25","completion_date":"2024-01-31","first_posted":"2023-12-19","last_update":"2023-12-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06176313","reference_pmids":[],"brief_summary":"The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms. Research Hypotheses: H01: Mandala activity is not effective in reducing premenstrual symptoms. H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms. H13: Mandala activity is effective in reducing premenstrual symptoms. H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms. H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS. Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group."},
{"id":"NCT06052722","registry":"ClinicalTrials.gov","slug":"the-relationship-of-premenstrual-syndrome-and-primary-nct06052722","match":"direct","title":"The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders","official_title":"The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"SCREENING","conditions":["Primary Dysmenorrhea","Premenstrual Syndrome","Temporomandibular Disorder"],"keywords":["Primary Dysmenorrhea","Premenstrual Syndrome","Temporomandibular Disorder","Correlation","Relationship"],"interventions":[{"type":"OTHER","name":"Correlation assessment"}],"sponsor":"Tokat Gaziosmanpasa University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":60,"enrollment_type":"ESTIMATED","start_date":"2023-10-01","completion_date":"2023-12-31","first_posted":"2023-09-25","last_update":"2023-09-25","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06052722","reference_pmids":[],"brief_summary":"Premenstrual pain, menstrual pain, other pains, and somatic symptoms may occur together. Therefore, this study aims to examine the severity of temporomandibular disorders in individuals complaining of premenstrual syndrome or dysmenorrhea and its relationship."},
{"id":"NCT05665972","registry":"ClinicalTrials.gov","slug":"effects-of-mandala-coloring-on-premenstrual-syndrome-nct05665972","match":"direct","title":"Effects of Mandala Coloring on Premenstrual Syndrome","official_title":"Effects of Mandala Coloring on Premenstrual Syndrome: Randomized Controlled Experimental Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","Mandala coloring"],"interventions":[{"type":"OTHER","name":"Mandala coloring"}],"sponsor":"Kırklareli University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":80,"enrollment_type":"ACTUAL","start_date":"2023-10-01","completion_date":"2024-06-11","first_posted":"2022-12-27","last_update":"2024-07-18","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05665972","reference_pmids":["41177972"],"brief_summary":"This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome."},
{"id":"NCT06146673","registry":"ClinicalTrials.gov","slug":"a-multidimensional-study-of-premenstrual-syndrome-and-body-nct06146673","match":"direct","title":"A Multidimensional Study of Premenstrual Syndrome and Body Image","official_title":"A Multidimensional Study of Premenstrual Syndrome, Body Image, Physical Activity and Sleep Quality Among Women in Reproductive Age","acronym":null,"status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Body Image","Premenstrual Syndrome","Sleep","Physical Inactivity"],"keywords":["physical activity","premenstrual syndrome","body mass index","24 hour movement behaviour","sleep quality","body image"],"interventions":[],"sponsor":"University of Pecs","sponsor_class":"OTHER","collaborators":[],"countries":["Hungary"],"enrollment":329,"enrollment_type":"ESTIMATED","start_date":"2023-09-01","completion_date":"2024-08-31","first_posted":"2023-11-27","last_update":"2023-11-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06146673","reference_pmids":["39449387"],"brief_summary":"The goal of this cross-sectional study is to investigate the influencing factors of body image in women of reproductive age. The main question\\[s\\] it aims to answer are: * Is there a connection between physical activity, body mass index and body image? * Is there a connection between body image, premenstrual syndrome and sleep quality? Participants will fill out a complex online questionnaire."},
{"id":"NCT06124326","registry":"ClinicalTrials.gov","slug":"a-single-group-study-to-evaluate-the-effects-of-a-supplement-nct06124326","match":"direct","title":"A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome","official_title":"A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Premenstrual Syndrome Supplement"}],"sponsor":"Rael","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2023-08-31","completion_date":"2024-01-20","first_posted":"2023-11-09","last_update":"2024-08-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06124326","reference_pmids":[],"brief_summary":"This is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle. Questionnaires will be completed at the following time points: * Baseline * Day 7 of their first cycle during the trial (After using the product PRN during their period) * 4 days before their second period during the trial (After using the product PRN for the previous month) * Day 3 of their second period during the trial (After using the product for 7 days straight) * Day 3 of their third period of the trial (After using the product for 7 days straight)"},
{"id":"NCT06136104","registry":"ClinicalTrials.gov","slug":"the-effects-of-mixhers-hertime-supplements-on-menstrual-nct06136104","match":"direct","title":"The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms","official_title":"The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Healthy","Premenstrual Dysphoric Disorder","Premenstrual Syndrome"],"keywords":["PMS (Premenstrual syndrome)","PMDD (Premenstrual dysphoric disorder)","Period Symptoms","Menstrual Cycle","Menstrual Cramping","Menstrual Bleeding"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Mixhers HERTIME"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"sponsor":"Midwestern University","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2023-08-30","completion_date":"2023-12-20","first_posted":"2023-11-18","last_update":"2024-05-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06136104","reference_pmids":[],"brief_summary":"The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms."},
{"id":"NCT06124300","registry":"ClinicalTrials.gov","slug":"effects-of-a-female-hormone-balance-supplement-on-symptoms-nct06124300","match":"direct","title":"Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome","official_title":"A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"OTHER","conditions":["Polycystic Ovary Syndrome","Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Female Hormone Balance Supplement"}],"sponsor":"Rael","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2023-08-30","completion_date":"2024-01-19","first_posted":"2023-11-09","last_update":"2024-08-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06124300","reference_pmids":[],"brief_summary":"This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks"},
{"id":"NCT06095232","registry":"ClinicalTrials.gov","slug":"pilot-study-to-investigate-dietary-changes-during-pregnancy-nct06095232","match":"related","title":"Pilot Study to Investigate Dietary Changes During Pregnancy","official_title":"Pilot Study to Investigate Dietary Changes During Pregnancy","acronym":null,"status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Pregnancy Related"],"keywords":["Pregnancy","Menstrual cycle","Nutrition","Cognition"],"interventions":[],"sponsor":"German Institute of Human Nutrition","sponsor_class":"OTHER","collaborators":[],"countries":["Germany"],"enrollment":156,"enrollment_type":"ESTIMATED","start_date":"2023-08-19","completion_date":"2025-08","first_posted":"2023-10-23","last_update":"2023-10-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06095232","reference_pmids":[],"brief_summary":"The aim of this pilot study is to investigate dietary choices and composition during pregnancy and fluctuating sex hormones during the natural menstrual cycle in women. In particular, the investigators are interested in the relationship between diet choice, cognitive performance and diversity of the gut microbiome. The study will be conducted in a longitudinal/cross-sectional design. Primiparous pregnant women will be investigated during four different time periods (during the 1st-3rd trimester and during the postpartum period). Women with a natural regular menstrual cycle will be assessed during two different hormonal phases of the cycle (early follicular, luteal) and undergo the same study design as pregnant women. Participants will conduct online tasks related to cognitive performance, food approach/avoidance behavior and risk assessment, fill out online questionnaires related to diet, mood, sleep and mental-wellbeing. In addition, participants will log their daily food intake for three days in a food diary and send in a stool sample in order to analyse gut microbiome composition."},
{"id":"NCT05924334","registry":"ClinicalTrials.gov","slug":"reiki-premenstrual-syndrome-quality-of-life-nct05924334","match":"direct","title":"Reiki & Premenstrual Syndrome & Quality of Life","official_title":"Effect of Kundalini Reiki Intervention on the Symptoms of Premenstrual Syndrome and Quality of Life in Nursing Students: Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Quality of Life"],"keywords":["quality of life","reiki","premenstrual syndrome"],"interventions":[{"type":"OTHER","name":"reiki"},{"type":"OTHER","name":"placebo"}],"sponsor":"Ege University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":90,"enrollment_type":"ACTUAL","start_date":"2023-08-04","completion_date":"2023-08-14","first_posted":"2023-06-29","last_update":"2023-11-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05924334","reference_pmids":[],"brief_summary":"It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome."},
{"id":"NCT05998044","registry":"ClinicalTrials.gov","slug":"effect-of-video-based-exercise-on-premenstrual-symptoms-a-nct05998044","match":"direct","title":"Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial","official_title":"Effect of Video-based Exercise on Premenstrual Symptoms: a Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Stress"],"keywords":["stress","Pilates Based Exercises"],"interventions":[{"type":"OTHER","name":"Pilates Based Exercises"},{"type":"OTHER","name":"control"}],"sponsor":"Uskudar University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":50,"enrollment_type":"ACTUAL","start_date":"2023-08-01","completion_date":"2023-10-12","first_posted":"2023-08-18","last_update":"2023-10-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05998044","reference_pmids":["12725453","22030232","23016028","25279689","33246104"],"brief_summary":"The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity."},
{"id":"NCT06000579","registry":"ClinicalTrials.gov","slug":"the-effect-of-emotional-freedom-technique-on-premenstrual-nct06000579","match":"direct","title":"The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students","official_title":"The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students: A Randomized Controlled","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Emotional Regulation, Premenstrual Syndrome"],"interventions":[{"type":"OTHER","name":"EFT"}],"sponsor":"KTO Karatay University","sponsor_class":"OTHER","collaborators":["EMEL EGE","KAMİLE ALTUNTUĞ","Merve YAZAR"],"countries":["Turkey (Türkiye)"],"enrollment":44,"enrollment_type":"ACTUAL","start_date":"2023-07-15","completion_date":"2023-09-11","first_posted":"2023-08-21","last_update":"2024-06-25","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06000579","reference_pmids":[],"brief_summary":"PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and 14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes. In addition to physical symptoms, studies indicate that individuals reporting PMS experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations. Studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression. It is thought that modulating many PMS symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future PMS interventions."},
{"id":"NCT06018168","registry":"ClinicalTrials.gov","slug":"an-rct-evaluating-the-efficacy-of-a-skincare-routine-and-nct06018168","match":"direct","title":"An RCT Evaluating the Efficacy of a Skincare Routine and Acne Supplement on Improving Acne and Other Symptoms of PMS","official_title":"A Randomized, Controlled Study Evaluating the Efficacy of a Skincare Routine and Acne Supplement or a Skincare Routine Alone on Improving Acne and Other Symptoms of PMS","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Acne","Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Skincare Routine"},{"type":"DIETARY_SUPPLEMENT","name":"MINDBODYSKIN Supplement"}],"sponsor":"Clearstem Skincare","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"2023-06-30","completion_date":"2024-01-10","first_posted":"2023-08-30","last_update":"2024-02-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06018168","reference_pmids":[],"brief_summary":"This study aims to evaluate the efficacy of the MINDBODYSKIN Hormonal Acne Supplement and a prescribed skincare routine of 6 products on facial acne and on symptoms of PMS, compared to a skincare routine of 6 products alone. This study will last for 24 weeks. The study will be conducted as a randomized, controlled trial in which participants will be split into two groups. Both will use the skincare routine, but one group will also take the MINDBODYSKIN supplement in combination with the skincare routine."},
{"id":"NCT05761899","registry":"ClinicalTrials.gov","slug":"safety-and-efficacy-of-pmt-therapy-of-hpap-nct05761899","match":"direct","title":"Safety and Efficacy of PMT Therapy of hPAP","official_title":"A First-In-Human Clinical Trial of Lentiviral-mediated CSF2RA Gene Transfer/Pulmonary Macrophage Transplantation Therapy of Hereditary Pulmonary Alveolar Proteinosis","acronym":null,"status":"RECRUITING","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Hereditary Pulmonary Alveolar Proteinosis"],"keywords":["Pulmonary Alveolar Proteinosis","Pulmonary Macrophage Transplantation"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Gene-Corrected Macrophages administered by bronchoscopic instillation"}],"sponsor":"Children's Hospital Medical Center, Cincinnati","sponsor_class":"OTHER","collaborators":["National Heart, Lung, and Blood Institute (NHLBI)","University of South Florida"],"countries":["United States"],"enrollment":3,"enrollment_type":"ESTIMATED","start_date":"2023-06-26","completion_date":"2038-10-01","first_posted":"2023-03-09","last_update":"2025-12-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05761899","reference_pmids":[],"brief_summary":"The major goal of this study is to evaluate a new type of cell transplantation therapy for individuals with hereditary PAP, study a new treatment that may be useful for treatment of other diseases, and research mechanisms that drive the development and function of lung macrophages."},
{"id":"NCT07360197","registry":"ClinicalTrials.gov","slug":"mbsr-for-premenstrual-syndrome-and-childbirth-fear-nct07360197","match":"direct","title":"MBSR for Premenstrual Syndrome and Childbirth Fear","official_title":"The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Fear of Childbirth","Psychological Well-being"],"keywords":["Mindfulness-Based Stress Reduction","MBSR","Premenstrual Syndrome","Childbirth Fear","Psychological Well-being","Women's Mental Health","Behavioral Intervention","Randomized Controlled Trial"],"interventions":[{"type":"BEHAVIORAL","name":"MBSR Intervention Group"}],"sponsor":"Aysel AKBENIZ","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":126,"enrollment_type":"ACTUAL","start_date":"2023-06-01","completion_date":"2025-11-01","first_posted":"2026-01-22","last_update":"2026-01-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07360197","reference_pmids":[],"brief_summary":"This randomized controlled trial evaluates the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS). PMS is a prevalent condition characterized by emotional, cognitive, and physical symptoms that significantly impair women's daily functioning, stress tolerance, and quality of life. In addition to its somatic and affective burden, PMS is associated with increased anxiety and emotional dysregulation, which may contribute to elevated fear related to pregnancy and childbirth during the preconception period. A total of 126 women aged 18 years and older who met the diagnostic threshold for PMS (Premenstrual Syndrome Scale score ≥ 110) were enrolled between June 2023 and November 2025 and randomly assigned in a 1:1 ratio to either an MBSR intervention group or a control group. The intervention group received an eight-session online MBSR program delivered twice weekly, with each session lasting 40 minutes. The program included mindfulness-based practices such as body scan, breath awareness, emotion-focused mindfulness, and cognitive awareness exercises, supported by structured home practice assignments. The control group received no active intervention during the study period. Primary and secondary outcomes were assessed using validated self-report instruments at baseline and after completion of the 8-week intervention period. Premenstrual symptom severity was measured using the Premenstrual Syndrome Scale (PMSS), fear of childbirth was evaluated with the Childbirth Fear-Prior to Pregnancy Scale (CF-PPS), and psychological well-being was assessed using the Psychological Well-Being Scale (PWBS). The primary objective of the study is to determine whether participation in the MBSR program leads to a greater reduction in premenstrual symptom severity compared to a control condition. Secondary objectives include evaluating the effect of MBSR on reducing fear of childbirth and improving psychological well-being. This study aims to provide evidence for the effectiveness of a non-pharmacological, mindfulness-based intervention in supporting women's mental and reproductive health during the premenstrual period."},
{"id":"NCT07047222","registry":"ClinicalTrials.gov","slug":"improving-menstrual-health-through-bcc-among-bangladeshi-nct07047222","match":"direct","title":"Improving Menstrual Health Through BCC Among Bangladeshi University Students","official_title":"Behavioral Change Communication Intervention in Menstrual Disorder Management Among Female University Students in Bangladesh","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Dysmenorrhea","Premenstrual Syndrome-PMS","Menstrual Irregularity"],"keywords":["Menstrual Health","Menstrual disorders","Behavior Change Communication","Lifestyle Intervention","Female University Students","BCC Module","Dietary Diversity","Physical Activity","Bangladesh","Propensity Score Matching (PSM)"],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral change communication (BCC) module"}],"sponsor":"Shahjalal University of Science and Technology","sponsor_class":"OTHER","collaborators":[],"countries":["Bangladesh"],"enrollment":498,"enrollment_type":"ACTUAL","start_date":"2023-05-20","completion_date":"2024-03-31","first_posted":"2025-07-02","last_update":"2025-07-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07047222","reference_pmids":["12758227","12920618","14726171","30777053","32659995","33239350","36539795","36612891","39321166","7137249"],"brief_summary":"This study evaluated the effectiveness of a Behavior Change Communication (BCC) intervention in improving menstrual health among female university students in Bangladesh. The intervention focused on three outcomes: dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularity (MI), promoting a non-pharmacological, sustainable approach through behavioral and lifestyle changes. Three structured educational sessions on menstrual health, healthy diet, and physical activity were delivered by trained female educators between May 20 and June 30, 2023, at Patuakhali Science and Technology University, Barishal University, and Khulna University. Participation was voluntary. Reinforcement follow-ups were conducted every two months for six months. A quasi-experimental design was employed. Post-intervention data were collected from February to March 2024. Based on sample size calculations assuming a 30% reduction in disorder prevalence, 498 students (249 per group) were initially enrolled. After exclusions, 234 intervention and 238 control participants were analyzed for dysmenorrhea; 228 per group for PMS and MI. Propensity score matching (1:1, caliper 0.01, no replacement) yielded 98 matched participants per group for final analysis. Eligible participants were female students aged ≥19 years, residing in university dormitories. Data collection used validated Bengali-language, interviewer-administered questionnaires, based on relevant literature and menstrual health IEC materials. Trained female enumerators ensured data quality and participant comfort. Primary outcomes were: (1) Dysmenorrhea, measured by the Andersch and Milsom score (dichotomized Yes/No); (2) PMS, assessed using the Premenstrual Symptoms Screening Tool, with no/mild PMS and moderate to severe PMS/PMDD as the outcome; (3) MI, defined as self-reported menstrual cycles \\<21 or \\>35 days. The treatment variable was BCC exposure (Yes/No). Covariates included physical activity, BMI, dietary diversity (DDS ≥5), food cravings, breakfast skipping, sleep duration, caffeine use, bedtime, family history of menstrual disorders, age at menarche, marital status, residence, and parental education and occupation. Baseline differences were assessed using descriptive statistics, chi-square, and t-tests. Conditional logistic regression estimated intervention effects on matched data. Sensitivity analyses (ATE, ATT, balance diagnostics, Bayesian logistic regression) supported the robustness of results."},
{"id":"NCT05859399","registry":"ClinicalTrials.gov","slug":"the-effect-of-laughter-yoga-on-premenstrual-symptoms-and-nct05859399","match":"direct","title":"The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students","official_title":"The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students With Premenstrual Syndrome","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Quality of Life"],"keywords":["Premenstrual Syndrome","Quality of life","Laughter yoga","Laughter therapy","Student"],"interventions":[{"type":"OTHER","name":"Laughter yoga"}],"sponsor":"Mersin University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":58,"enrollment_type":"ESTIMATED","start_date":"2023-05-15","completion_date":"2023-12-31","first_posted":"2023-05-16","last_update":"2023-05-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05859399","reference_pmids":[],"brief_summary":"The research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life. Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. H1: Online laughter yoga has an effect on premenstrual symptoms. H0: Online laughter yoga has no effect on quality of life. H1: Online laughter yoga has an impact on quality of life."},
{"id":"NCT06026540","registry":"ClinicalTrials.gov","slug":"the-effect-of-peer-guided-pilates-exercise-on-premenstrual-nct06026540","match":"direct","title":"The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study","official_title":"The Effect of Peer-Guided Pilates Exercise on Premenstrual Syndrome Symptoms and Healthy Lifestyle Behaviors: A Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["healthy living","Peer guidance","pilates exercise","premenstrual syndrome"],"interventions":[{"type":"BEHAVIORAL","name":"Pilates Exercise"}],"sponsor":"Istanbul University - Cerrahpasa","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":54,"enrollment_type":"ACTUAL","start_date":"2023-05-01","completion_date":"2024-03-01","first_posted":"2023-09-07","last_update":"2024-10-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06026540","reference_pmids":["28318414","32522750","33386201","34879766","35534402"],"brief_summary":"This project is to examine the effect of pilates exercise, which is applied by university students under the guidance of peers, on premenstrual syndrome symptoms and healthy lifestyle behaviors. Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. The population of the research consists of 385 female students studying at the Department of Midwifery at Istanbul University-Cerrahpaşa Faculty of Health Sciences. In the study, it is aimed to reach all students without making a sample calculation in order to identify the students with PMS symptoms among all students. Students who score 110 and above on the Premenstrual Syndrome Scale (PMSS) will be considered to have PMS symptoms. The sample size of the students showing PMS symptoms was determined by using the G\\*Power (3.1.9.2) program and considering the 0.05 margin of error and data loss, according to 95% power and medium effect size; 27 people should be included in the experimental group and 27 people in the control group. In determining the groups, the participants will be assigned to the experimental and control groups using the \"Randomizer.org\" program. Students included in the research will be given information about the study and will be presented with an \"Informed Consent Form\" and a \"Volunteer Consent Form\". While the experimental group will be given pilates exercises, under the guidance of a peer, for half an hour twice a week for six months, the control group will maintain their routine habits. At the beginning of the study, data will be collected with the \"Personal Information Form\", \"Premenstrual Syndrome Scale (PMSÖ)\" and \"Healthy Lifestyle Behaviors Scale-II (SYBDS-II)\". In the third and sixth months of the study, the hypotheses will be tested by applying PMSS and HLBS-II. The data obtained in the research will be entered into the database in the IBM SPSS 25.0 (Statistical Package for the Social Sciences) program and all necessary statistical analyzes will be performed in the same program."},
{"id":"NCT05900024","registry":"ClinicalTrials.gov","slug":"a-study-to-evaluate-the-effect-of-funk-it-cycle-bites-on-pms-nct05900024","match":"direct","title":"A Study to Evaluate the Effect of Funk It Cycle Bites on PMS","official_title":"An Open-Label, Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Funk It Cycle Bites"}],"sponsor":"Funk It Wellness","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":30,"enrollment_type":"ACTUAL","start_date":"2023-05-01","completion_date":"2023-10-01","first_posted":"2023-06-12","last_update":"2024-02-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05900024","reference_pmids":[],"brief_summary":"This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS. Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores."},
{"id":"NCT05707845","registry":"ClinicalTrials.gov","slug":"effect-of-weight-reduction-and-aerobic-exercise-on-pms-nct05707845","match":"direct","title":"Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females","official_title":"Effect of Weight Reduction and Aerobic Exercise on Premenstrual Syndrome Symptoms in Obese Females","acronym":"PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["\"premenstrual syndrome\"","\"diet\"","\"exercise\"","\"obesity\""],"interventions":[{"type":"DRUG","name":"Medical treatment."},{"type":"BEHAVIORAL","name":"weight reduction"},{"type":"OTHER","name":"exercise"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2023-05-01","completion_date":"2023-12-01","first_posted":"2023-02-01","last_update":"2024-06-11","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05707845","reference_pmids":["28650737","31867375","35871162"],"brief_summary":"The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females."},
{"id":"NCT05823207","registry":"ClinicalTrials.gov","slug":"effect-of-sage-essential-oil-inhalation-aromatherapy-on-nct05823207","match":"direct","title":"Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Symptoms and Quality of Life","official_title":"Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Syndrome and Quality of Life: A Randomized Controlled Study","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Anxiety"],"keywords":["premenstrual syndrome","aromatherapy","students","sage oil"],"interventions":[{"type":"OTHER","name":"sage essential oil"}],"sponsor":"Cansu Mine Aydin","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":86,"enrollment_type":"ESTIMATED","start_date":"2023-05","completion_date":"2024-06-30","first_posted":"2023-04-21","last_update":"2023-05-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05823207","reference_pmids":[],"brief_summary":"The changes (mood changes, lethargy, irritability, etc.) that gradually disappear with the start of the menstrual period in women are called premenstrual syndrome. Anxiety, irritability, poor concentration, depression, mood swings, lethargy, sleep disturbance, breast tenderness, change in appetite, bloating, headache, weight gain, abdominal pain, fatigue, and gastrointestinal symptoms are seen in this syndrome. Safe and effective treatments are needed as these symptoms negatively affect both work and personal lives of women. Some women also turned to therapeutic approaches due to the high side effects of pharmacological treatment. One of these approaches is the aromatherapy method, which is widely used today. Aromatherapy is a therapy aimed at protecting and improving one's physical, mental and psychological health. Traditionally, aromatherapy has been used as one of the non-pharmacological methods for reducing premenstrual symptoms, releasing uterine cramps, and reducing pain and anxiety. Sage oil, with its ester components, regulates the menstrual cycle and hormonal components and alleviates climatic changes and symptoms in menopausal women. It is also recommended to use sage essential oil to reduce uterine tonics and to reduce fluid retention in the premenstrual period. In our country, no study was found in which aromatherapy was performed using sage oil in PMS. It is thought that the study to be conducted in this area will be beneficial in terms of evaluating the effectiveness of a non-pharmacological method in the treatment of PMS."},
{"id":"NCT05813366","registry":"ClinicalTrials.gov","slug":"combined-effect-of-tryptophan-rich-diet-and-acupuncture-on-nct05813366","match":"direct","title":"Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder","official_title":"Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"OTHER","name":"Acupuncture"},{"type":"OTHER","name":"Tryptophan-Rich Diet"},{"type":"OTHER","name":"Vitamin B6 Supplementation"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":39,"enrollment_type":"ESTIMATED","start_date":"2023-04-25","completion_date":"2023-07-25","first_posted":"2023-04-14","last_update":"2023-04-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05813366","reference_pmids":[],"brief_summary":"Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome (PMS) affecting up to 8% of reproductive age women. It is characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and leads to negative impact on the psychosocial functioning of affected individuals. Selective serotonin reuptake inhibitors are usually used to treat PMDD but they have several side effects so it is important to use complementary treatment such as tryptophan-rich diet and acupuncture for women with PMDD . The purpose of the current study is to determine the combined effect of tryptophan-rich diet and acupuncture on depression related to premenstrual dysphoric disorder"},
{"id":"NCT05528926","registry":"ClinicalTrials.gov","slug":"resist-against-irritability-superiority-trial-nct05528926","match":"direct","title":"RESist Against Irritability Superiority Trial","official_title":"Parent Training for the Treatment of Irritability in Children and Adolescents: a Multisite Randomized Controlled, 3-parallel-group, Evaluator-blinded, Superiority Trial","acronym":"RESIST","status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Irritable Mood"],"keywords":["Irritability","Parent Management Training (PMT)","Non-Violent Resistance (NVR)"],"interventions":[{"type":"OTHER","name":"Non-Violent Resistance"},{"type":"OTHER","name":"Parent Management Training"},{"type":"DRUG","name":"Treatment As Usual"}],"sponsor":"University Hospital, Montpellier","sponsor_class":"OTHER","collaborators":[],"countries":["France"],"enrollment":270,"enrollment_type":"ESTIMATED","start_date":"2023-04-25","completion_date":"2026-09-01","first_posted":"2022-09-06","last_update":"2023-08-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05528926","reference_pmids":["36414963"],"brief_summary":"Irritability is defined as developmentally inappropriate proneness to anger. Irritability is a symptom of several mental health conditions in children and adolescents such as attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder (CD), depressive disorders, anxiety disorders.Irritability has been associated with poor functional outcomes across the lifespan and was found to be specifically associated with concurrent and longitudinal emotional disorders, suicidality and impaired academic and socio-professional functioning. Children with high irritability also have distinct physiological profiles with hyper-reactivity to stress and perceived threats. Despite the high prevalence and health issues related to irritability, there is little treatment research on this topic. Developing evidence-based non-pharmacological treatment options for children suffering from severe, chronic irritability is therefore a particularly important target for clinical research."},
{"id":"NCT05817513","registry":"ClinicalTrials.gov","slug":"effect-of-myofascial-release-on-scoliotic-females-with-nct05817513","match":"direct","title":"Effect of Myofascial Release on Scoliotic Females With Dysmenorrhea.","official_title":"Effect of Myofascial Release on Spinal Curvature, Pre Menstrual Symptoms and Quality of Life in Scoliotic Females With Dysmenorrhea.","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Scoliosis Idiopathic Adolescent","Dysmenorrhea","Premenstrual Syndrome","Quality of Life"],"keywords":["Scoliosis , dysmenorrhea, Myofascial release, pre Menstrual symptoms"],"interventions":[{"type":"OTHER","name":"Myofascial release."},{"type":"OTHER","name":"Traditional exercises for scoliosis treatment."}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":52,"enrollment_type":"ACTUAL","start_date":"2023-04-01","completion_date":"2023-12-01","first_posted":"2023-04-18","last_update":"2024-10-10","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05817513","reference_pmids":[],"brief_summary":"PURPOSE: The purpose of this study is to determine the effect of myofascial release on spinal curvature, premenstrual symptoms, and quality of life in scoliotic females with dysmenorrhea"},
{"id":"NCT06307119","registry":"ClinicalTrials.gov","slug":"model-of-human-occupation-based-intervention-on-premenstrual-nct06307119","match":"direct","title":"Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms","official_title":"The Effectiveness of Model of Human Occupation-Based Intervention on Occupational Participation in Individuals With Premenstrual Syndrome Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Occupational Therapy and Relaxation Group"},{"type":"BEHAVIORAL","name":"Relaxation Group"}],"sponsor":"Saglik Bilimleri Universitesi","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":95,"enrollment_type":"ACTUAL","start_date":"2023-03-01","completion_date":"2024-03-02","first_posted":"2024-03-12","last_update":"2024-03-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06307119","reference_pmids":[],"brief_summary":"This study was conducted to examine the effect of two different occupational therapy interventions on premenstrual syndrome symptoms in university students. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study."},
{"id":"NCT05845970","registry":"ClinicalTrials.gov","slug":"an-investigation-into-the-efficacy-of-a-botanical-supplement-nct05845970","match":"direct","title":"An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief","official_title":"An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief","acronym":null,"status":"COMPLETED","phases":["PHASE1"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Menstrual Pain","Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Pamprin Botanicals"},{"type":"COMBINATION_PRODUCT","name":"Pamprin Botanicals + Pamprin Menstrual Pain Relief"}],"sponsor":"Focus Consumer Healthcare","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2023-02-08","completion_date":"2023-07-01","first_posted":"2023-05-06","last_update":"2024-02-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05845970","reference_pmids":[],"brief_summary":"Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial."},
{"id":"NCT05098574","registry":"ClinicalTrials.gov","slug":"oral-contraceptives-for-treating-premenstrual-dysphoric-nct05098574","match":"direct","title":"Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder","official_title":"A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder with Oral Contraceptives in Bipolar Disorder.","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder","Bipolar Disorder"],"keywords":["bipolar disorder","premenstrual dysphoric disorder"],"interventions":[{"type":"DRUG","name":"Yaz"},{"type":"DRUG","name":"Placebo"}],"sponsor":"St. Joseph's Healthcare Hamilton","sponsor_class":"OTHER","collaborators":["Hamilton Academic Health Sciences Organization","McMaster University"],"countries":["Canada"],"enrollment":17,"enrollment_type":"ACTUAL","start_date":"2023-02-03","completion_date":"2024-04-11","first_posted":"2021-10-28","last_update":"2024-09-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05098574","reference_pmids":["37365881"],"brief_summary":"This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives. Lay Summary: This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians. One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people."},
{"id":"NCT05507255","registry":"ClinicalTrials.gov","slug":"effect-of-aerobic-exercise-on-diurnal-cortisol-pattern-in-nct05507255","match":"direct","title":"Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome","official_title":"Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Aerobic exercise","Relaxation training","Diurnal cortisol pattern","Premenstrual syndrome"],"interventions":[{"type":"OTHER","name":"Relaxation training"},{"type":"OTHER","name":"An aerobic exercise program"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":28,"enrollment_type":"ACTUAL","start_date":"2023-02-01","completion_date":"2023-06-01","first_posted":"2022-08-18","last_update":"2023-06-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05507255","reference_pmids":[],"brief_summary":"The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome."},
{"id":"NCT05518006","registry":"ClinicalTrials.gov","slug":"an-investigation-of-premama-balance-and-its-effects-on-nct05518006","match":"direct","title":"An Investigation of Premama Balance and Its Effects on Hormonal Imbalances","official_title":"An Exploratory Investigation of Dietary Supplementation and the Effect on the Regularity of Menstrual Cycles, Hormone Balance, and Common PMS Symptoms in Females","acronym":null,"status":"WITHDRAWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["PMS","Menstrual Discomfort","Hormone Disturbance","Menstrual Pain","Menstrual Irregularity"],"keywords":["PMS","Menstrual Discomfort","Hormone Disturbance","Menstrual Pain","Menstrual Irregularity"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"PreMama Balance"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo Drink"}],"sponsor":"Premama Inc.","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":[],"enrollment":0,"enrollment_type":"ACTUAL","start_date":"2022-12-30","completion_date":"2023-06-30","first_posted":"2022-08-26","last_update":"2024-04-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05518006","reference_pmids":[],"brief_summary":"An investigation of the dietary supplement marketed as \"Premama Balance\" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle."},
{"id":"NCT05644613","registry":"ClinicalTrials.gov","slug":"comparative-study-between-the-effect-of-aerobic-exercises-on-nct05644613","match":"direct","title":"Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome","official_title":"Effect Of Aerobic Exercises On Land Versus Aerobic Exercises In Water In The Management Of Premenstrual Syndrome In Adolescent Girls","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["premenstrual syndrome"],"interventions":[{"type":"OTHER","name":"aerobic exercise on land"},{"type":"OTHER","name":"aerobic exercise in water"}],"sponsor":"Mariam Hossam El Ebrashy","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":40,"enrollment_type":"ESTIMATED","start_date":"2022-12-15","completion_date":"2023-04-30","first_posted":"2022-12-09","last_update":"2023-01-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05644613","reference_pmids":[],"brief_summary":"Many girls experience premenstrual syndrome PMS which is re a group of physical, cognitive, affective, and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve at or within a few days of the onset of menstruation. In young adolescents symptoms might particularly affect school functions, and social interactions in a negative ways in this study we will figure out the effect of 2 kinds of exercises in the management of this syndrome."},
{"id":"NCT05834127","registry":"ClinicalTrials.gov","slug":"effects-of-aerobic-exercises-and-yoga-on-premenstrual-nct05834127","match":"direct","title":"Effects of Aerobic Exercises and Yoga on Premenstrual Syndrome","official_title":"Comparative Effects of Aerobic Exercises and Yoga on Pain and Symptoms Severity in Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Pain"],"keywords":["Aerobic exercises","Menstruation","Premenstrual syndrome","Visual analogue scale","Yoga"],"interventions":[{"type":"OTHER","name":"Aerobic exercise"},{"type":"OTHER","name":"Yoga Exercises"}],"sponsor":"Riphah International University","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":36,"enrollment_type":"ACTUAL","start_date":"2022-11-20","completion_date":"2023-08-01","first_posted":"2023-04-28","last_update":"2023-12-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05834127","reference_pmids":["15358465","17291207","2197679","24701496","31221931","31867375","7739706"],"brief_summary":"Sign and symptoms including mood swings, sensitive breasts, food cravings, exhaustion, irritability, pain and sadness. The physical and emotional changes you go through with premenstrual syndrome can range from hardly perceptible to severe. Some people's physical discomfort and emotional stress are so severe that it interferes with their daily life. Regardless of the severity of the symptoms, most women's signs and symptoms go away four days following the start of their menstrual cycle. In this study the effects of aerobic exercises and Yoga on premenstrual syndrome population will be analyzed. This study will be a randomized clinical trial which will incorporate two different interventions. Aerobic exercises and yoga would be administered to the females. 32 patients will randomly divided into two groups. Assessment will be done by using PMS scale and visual analogue scale. The goal of this study to compare the effects of aerobic exercises and yoga on premenstrual syndrome."},
{"id":"NCT05725447","registry":"ClinicalTrials.gov","slug":"cross-cultural-adaptation-validity-and-reliability-of-the-nct05725447","match":"direct","title":"Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)","official_title":"Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","Turkish version","Translation","Reliability","Validity"],"interventions":[{"type":"OTHER","name":"Validity and reliability study"}],"sponsor":"Gazi University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":200,"enrollment_type":"ACTUAL","start_date":"2022-11-07","completion_date":"2022-12-30","first_posted":"2023-02-13","last_update":"2023-02-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05725447","reference_pmids":[],"brief_summary":"This study is aimed to carry out the Turkish version validity and reliability of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)."},
{"id":"NCT05692479","registry":"ClinicalTrials.gov","slug":"premenstrual-syndrome-and-physical-activity-self-worth-nct05692479","match":"direct","title":"Premenstrual Syndrome and Physical Activity Self-Worth","official_title":"Comparison of Physical Activity Self Worth of Women With and Without Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","women","self-worth","physical activity"],"interventions":[{"type":"OTHER","name":"Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data"}],"sponsor":"Nigde Omer Halisdemir University","sponsor_class":"OTHER","collaborators":["Ankara Yildirim Beyazıt University"],"countries":["Turkey (Türkiye)"],"enrollment":250,"enrollment_type":"ACTUAL","start_date":"2022-10-10","completion_date":"2023-02-28","first_posted":"2023-01-20","last_update":"2023-03-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05692479","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) negatively affects the quality of life of millions of women. PMS is a common cyclic disorder characterized by somatic, cognitive, emotional and behavioral symptoms that usually occurs in young and middle-aged women, lasts during the luteal phase of the menstrual cycle and ends with the onset of menstruation.Studies have shown that women with high PMS symptoms are more inactive. Physical activity participation in women affects a wide spectrum of self-perceptions, including knowledge, social, and emotional self-perceptions. By determining which physical, emotional, social and academic/knowledge areas are affected by women, increasing their participation in physical activity can be achieved. The subject of the study is to determine the symptom severity of women with and without premenstrual syndrome and to examine how premenstrual syndrome affects physical activity self-worth."},
{"id":"NCT06144073","registry":"ClinicalTrials.gov","slug":"the-effect-of-mandala-art-therapy-in-coping-with-nct06144073","match":"direct","title":"The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome","official_title":"The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome: A Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","Cope","Stress","Depression","Mandala"],"interventions":[{"type":"BEHAVIORAL","name":"Intervention (Mandala art therapy) group"}],"sponsor":"Kahramanmaras Sutcu Imam University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":120,"enrollment_type":"ACTUAL","start_date":"2022-10-06","completion_date":"2024-04-30","first_posted":"2023-11-22","last_update":"2025-06-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06144073","reference_pmids":["24410911"],"brief_summary":"Mandala practice will be applied to women with premenstrual syndrome. The intervention group (Mandala practice group) and the control group each consisted of 60 women."},
{"id":"NCT05556252","registry":"ClinicalTrials.gov","slug":"the-effect-of-hydrogen-rich-water-on-premenstrual-symptoms-nct05556252","match":"direct","title":"The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life","official_title":"The Effect of Hydrogen-rich Water Consumption on Premenstrual Symptoms and Quality of Life in Students With Premenstrual Syndrome: A Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Hydrogenated water consumption"},{"type":"OTHER","name":"Drinking water consumption"}],"sponsor":"Menekşe Nazlı AKER","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":72,"enrollment_type":"ACTUAL","start_date":"2022-10-01","completion_date":"2023-04-28","first_posted":"2022-09-27","last_update":"2023-06-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05556252","reference_pmids":[],"brief_summary":"The aim of this study is to determine the effect of hydrogenated water on premenstrual symptoms and quality of life in students with premenstrual syndrome. Research Hypotheses H1 1 Hydrogenated water consumption reduces premenstrual symptoms in students with premenstrual syndrome. H1 2 Hydrogenated water consumption increases the quality of life in students with premenstrual syndrome. The research will consist of intervention and control groups. Individuals consuming hydrogen-rich water will be included in the intervention group, whereas individuals consuming normal water will be in the control group. The block randomization method will be used to randomly assign participants who meet the research criteria to the groups. Participants will be provided with hydrogenated water for three cycles."},
{"id":"NCT06522126","registry":"ClinicalTrials.gov","slug":"the-effects-of-progressive-relaxation-exercise-nct06522126","match":"direct","title":"The Effects of Progressive Relaxation Exercise","official_title":"The Effects of Progressive Relaxation Exercise on Life Satisfaction, Anxiety, and Psychological Well-being in Students Experiencing Premenstrual Syndrome: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Effects of Progressive Relaxation Exercise","Exercise","Relation, Interpersonal"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"progressive relaxation exercise"}],"sponsor":"Inonu University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":162,"enrollment_type":"ACTUAL","start_date":"2022-09-01","completion_date":"2024-05-02","first_posted":"2024-07-26","last_update":"2024-08-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06522126","reference_pmids":[],"brief_summary":"Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome. Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests."},
{"id":"NCT05836454","registry":"ClinicalTrials.gov","slug":"the-soft-tissue-mobilization-techniques-on-pms-nct05836454","match":"direct","title":"The Soft Tissue Mobilization Techniques on PMS","official_title":"The Effect of Progressive Muscle Relaxation Technique and Myofascial Release Technique on Premenstrual Symptoms, Blood Circulation, and Quality of Life in Women With Premenstrual Syndrome: a Single-blind Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Premenstrual Pain","Chronic Pelvic Pain"],"keywords":["myofascial releasing technique","progressive relaxation technique","blood flow velocity"],"interventions":[{"type":"OTHER","name":"Progressive Muscle Relaxation Group:"},{"type":"OTHER","name":"Myofascial Release Technique Group"}],"sponsor":"Eastern Mediterranean University","sponsor_class":"OTHER","collaborators":[],"countries":["Cyprus"],"enrollment":94,"enrollment_type":"ACTUAL","start_date":"2022-09-01","completion_date":"2025-06-30","first_posted":"2023-05-01","last_update":"2025-07-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05836454","reference_pmids":[],"brief_summary":"The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment and post- treatment assessment will be done. Follow-up evaluation will be done on the fifth cycle, two cycles after the post-treatment evaluation."},
{"id":"NCT05499000","registry":"ClinicalTrials.gov","slug":"the-effect-of-emotional-freedom-technique-on-premenstrual-nct05499000","match":"direct","title":"The Effect of Emotional Freedom Technique on Premenstrual Syndrome","official_title":"The Effect of Emotional Freedom Technique on Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome","Emotional Problem"],"keywords":["Emotional Freedom Technique","Premenstruel Sendrom","Midwifery"],"interventions":[{"type":"BEHAVIORAL","name":"Emotional freedom technique"}],"sponsor":"Inonu University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":51,"enrollment_type":"ACTUAL","start_date":"2022-09-01","completion_date":"2023-09-01","first_posted":"2022-08-12","last_update":"2024-04-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05499000","reference_pmids":[],"brief_summary":"Objective: This study was conducted to evaluate the Effect of Emotional Freedom Technique on Premenstrual Syndrome. Methodology: The research will be conducted as a randomized controlled trial. The research will be carried out with students studying at the Department of Midwifery, Faculty of Health Sciences, İnönü University, between September and October 2022. The sample size of the study was calculated as 102 people with an effect size of 0.80 and a power of 0.95. Premenstrual syndrome scale will be applied to all students participating in the research first and those who score 110 and above will be listed. Experimental and control groups will be determined by randomization. Personal information form, subjective experience unit scale and premenstrual syndrome scale will be used to collect data. SPSS 22.0 package program will be used in the evaluation of the data. The independent variable of the research is the emotional liberation technique. The dependent variable of the study is the mean scores of the participants from the subjective experience unit scale and premenstrual syndrome scale."},
{"id":"NCT06227676","registry":"ClinicalTrials.gov","slug":"effect-of-cramp-bites-on-period-cramps-in-women-aged-18-25-nct06227676","match":"direct","title":"Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25","official_title":"Formative Assessment of the Effect of 'Cramp Bites' Intake on Primary Dysmenorrhea in Women Aged 18-25: A Placebo-Controlled Trial","acronym":"NUTRITION; GYN","status":"COMPLETED","phases":["PHASE2","PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Dysmenorrhea Primary","Dysmenorrhea","Menstrual Discomfort","Menstrual Problem","Menstrual Cycle Abnormal","Menstrual Pain","Period Pain","Period Problem","PMS","Premenstrual Syndrome","PCOS","PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries","PCOS (Polycystic Ovary Syndrome) of Left Ovary","PCOS (Polycystic Ovary Syndrome) of Right Ovary","Polycystic Ovary Syndrome","Premenstrual Dysphoric Disorder","Cramps","Ovarian Cysts"],"keywords":["Dysmenorrhea","Primary Dysmenorrhea","Menstrual Discomfort","Menstrual Pain","Menstrual Problem","Menstrual Cycle Abnormal","Period Pain","Period Problem","PMS","Premenstrual Syndrome","PCOS","PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries","PCOS (Polycystic Ovary Syndrome) of Left Ovary","PCOS (Polycystic Ovary Syndrome) of Right Ovary","Polycystic Ovary Syndrome","Premenstrual Dysphoric Disorder","Cramps","Ovarian Cysts"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Cramp Bites by Aunt Flo's Kitchen"}],"sponsor":"Cornell University","sponsor_class":"OTHER","collaborators":["Laidlaw Foundation","Epperson Fund","Beck Fellowship","Dan Cane Fund"],"countries":["United States"],"enrollment":12,"enrollment_type":"ACTUAL","start_date":"2022-07-21","completion_date":"2022-10-31","first_posted":"2024-01-29","last_update":"2024-04-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06227676","reference_pmids":["1238078","19786516","23798928","25059384","26346058","32559803","33030880","35320895","35523674","35883903"],"brief_summary":"85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms."},
{"id":"NCT05226494","registry":"ClinicalTrials.gov","slug":"safety-and-tolerability-of-fb-pmt-in-recurrent-glioblastoma-nct05226494","match":"direct","title":"Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma","official_title":"A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma","acronym":null,"status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Glioma, Malignant"],"keywords":["Glioblastoma","Glioblastoma Multiforme"],"interventions":[{"type":"DRUG","name":"fb-PMT"}],"sponsor":"NanoPharmaceuticals LLC","sponsor_class":"INDUSTRY","collaborators":[],"countries":["United States"],"enrollment":34,"enrollment_type":"ESTIMATED","start_date":"2022-06-23","completion_date":"2028-06","first_posted":"2022-02-07","last_update":"2026-08-31","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05226494","reference_pmids":[],"brief_summary":"Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma."},
{"id":"NCT05395156","registry":"ClinicalTrials.gov","slug":"effect-of-tens-on-acupoints-in-premenstrual-syndrome-nct05395156","match":"direct","title":"EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME","official_title":"EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Pain"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Transcutaneous electrical nerve stimulation (TENS)"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2022-06-10","completion_date":"2022-10-10","first_posted":"2022-05-27","last_update":"2022-05-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05395156","reference_pmids":[],"brief_summary":"These will be no effect of transcutaneous electrical acupoint stimulation on premenstrual syndrome Does transcutaneous electrical acupoint stimulation affect premenstrual syndrome (PMS)?"},
{"id":"NCT05588284","registry":"ClinicalTrials.gov","slug":"preservation-of-venous-valvular-function-after-pmt-for-acute-nct05588284","match":"direct","title":"Preservation of Venous Valvular Function After PMT for Acute DVT","official_title":"Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study","acronym":"PREFER","status":"ENROLLING_BY_INVITATION","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Acute Deep Venous Thrombosis of Femoral Vein (Disorder)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"AngioJet device"},{"type":"OTHER","name":"anticoagulation alone"}],"sponsor":"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","sponsor_class":"OTHER","collaborators":["Boston Scientific Corporation"],"countries":["China"],"enrollment":100,"enrollment_type":"ESTIMATED","start_date":"2022-06-06","completion_date":"2026-12-30","first_posted":"2022-10-20","last_update":"2026-05-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05588284","reference_pmids":[],"brief_summary":"To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis."},
{"id":"NCT05396976","registry":"ClinicalTrials.gov","slug":"the-effect-of-yoga-and-progressive-muscle-relaxation-nct05396976","match":"direct","title":"The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Premenstrual Syndrome","official_title":"The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Menstrual Symptoms, Depression, Anxiety and Stress in University Students: A Randomized Controlled Trial","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Yoga","Muscle Relaxation Exercise Practices","Depression, anxiety and stress"],"interventions":[{"type":"BEHAVIORAL","name":"Yoga and Muscle Relaxation Exercise Practices"}],"sponsor":"Eastern Mediterranean University","sponsor_class":"OTHER","collaborators":[],"countries":["Cyprus"],"enrollment":72,"enrollment_type":"ESTIMATED","start_date":"2022-06-01","completion_date":"2022-08-07","first_posted":"2022-05-31","last_update":"2022-05-31","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05396976","reference_pmids":["38343144"],"brief_summary":"Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Despite the conclusion that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome."},
{"id":"NCT05395169","registry":"ClinicalTrials.gov","slug":"effect-of-dash-diet-and-aerobic-exercises-on-premenstrual-nct05395169","match":"direct","title":"EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME","official_title":"EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Tension"],"keywords":[],"interventions":[{"type":"OTHER","name":"dietary supplement ,electronic treadmill ,DASH diet."}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2022-06-01","completion_date":"2022-10-01","first_posted":"2022-05-27","last_update":"2022-05-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05395169","reference_pmids":[],"brief_summary":"Hypothesis: There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome. Statement of the problem: Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?"},
{"id":"NCT05428813","registry":"ClinicalTrials.gov","slug":"the-effect-of-art-on-premenstrual-syndrome-symptoms-nct05428813","match":"direct","title":"The Effect of Art on Premenstrual Syndrome Symptoms","official_title":"The Effect of Art on Premenstrual Syndrome Symptoms: A Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome, Art, Women Health"],"interventions":[{"type":"BEHAVIORAL","name":"art therapy techniques"}],"sponsor":"Kutahya Health Sciences University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":72,"enrollment_type":"ACTUAL","start_date":"2022-04-15","completion_date":"2022-12-30","first_posted":"2022-06-23","last_update":"2023-02-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05428813","reference_pmids":["39042713"],"brief_summary":"This study will be conducted to determine the effect of art therapy techniques on premenstrual syndrome symptoms.The study is a randomized controlled type study. The study will be conducted with 70 female students with premenstrual syndrome. In the study, which consists of two groups, experimental (n=35) and control (n=35), art therapy techniques will be applied to the students in the experimental group for 8 weeks. The control group will continue their routine coping habits. Both groups will be evaluated with the Premenstrual Syndrome scale at the end of the study, and the difference between the groups will be examined."},
{"id":"NCT05340816","registry":"ClinicalTrials.gov","slug":"the-effects-of-manual-lymphatic-drainage-and-transcutaneous-nct05340816","match":"direct","title":"The Effects of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation in Premenstrual Syndrome","official_title":"The Effect of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation Methods in Women With Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Manual Lymphatic Drainage","Transcutaneous Electrical Nerve Stimulation","Premenstrual Syndrome","Quality of Life","Autonomic Functions"],"interventions":[{"type":"OTHER","name":"Manual Lymphatic Drainage"},{"type":"DEVICE","name":"Transcutaneous Electrical Nerve Stimulation"}],"sponsor":"Kutahya Health Sciences University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":42,"enrollment_type":"ACTUAL","start_date":"2022-04-04","completion_date":"2024-02-15","first_posted":"2022-04-22","last_update":"2025-03-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05340816","reference_pmids":["29855308","30057033","30712751"],"brief_summary":"The aim of this study is to (a) investigate the effects of manual lymphatic drainage and transcutaneous electrical nerve stimulation on the severity of syndrome symptoms, pain, heart rate variability, and quality of life in women with premenstrual syndrome, and (b) compare the effectiveness of these two methods. Female participants who met the inclusion criteria and volunteered to participate in the study will be called approximately one week before menstruation. After the participants are randomly divided into 3 groups, their baseline assessments will be made. Then, the participants will be treated according to the group they are assigned to. Treatments will be applied for 5 days and once a day. No treatment will be applied to the control group. The assessments will be repeated after the treatment, on 1st day of menstruation, two days before the next menstruation, and on the first day of the next menstruation. The hypothesis of this study is that manual lymphatic drainage and transcutaneous electrical nerve stimulation have positive effects on the severity of premenstrual syndrome symptoms, pain, heart rate variability, and quality of life."},
{"id":"NCT05709561","registry":"ClinicalTrials.gov","slug":"the-effect-of-acupressure-and-mindfulness-to-cope-with-nct05709561","match":"direct","title":"The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome (PMS) on PMS and Quality of Life","official_title":"The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome on Premenstrual Symptoms and Quality of Life","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Acupressure","Mındfulness","Nurse","Quality of life"],"interventions":[{"type":"PROCEDURE","name":"Acupresur"},{"type":"PROCEDURE","name":"Mindfulness"},{"type":"PROCEDURE","name":"Plasebo"}],"sponsor":"Inonu University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":270,"enrollment_type":"ACTUAL","start_date":"2022-03-31","completion_date":"2023-03-15","first_posted":"2023-02-02","last_update":"2023-07-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05709561","reference_pmids":[],"brief_summary":"The research was carried out to determine the effect of acupressure and mindfulness practice to cope with premenstrual syndrome on premenstrual symptoms and quality of life. The sample of the study consisted of a total of 270 students, 90 of which were acupressure, 90 mindfulness and 90 control groups. In the study, data were collected with the Participant Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. In the mindfulness group, 8 weeks of Conscious Awareness Stress Reduction Program was applied, after which the students were asked to practice mindfulness for 3 cycles. Students in both experimental groups were asked to stop the practices after acupressure and mindfulness practices. PMSS and WHOQOL-BREF were applied to both experimental and control groups as an intermediate test 12 weeks after the pre-test and a post-test 24 weeks later."},
{"id":"NCT05428800","registry":"ClinicalTrials.gov","slug":"the-effect-of-progressive-relaxation-exercises-on-nct05428800","match":"direct","title":"The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms","official_title":"The Effect of Progressive Relaxation Exercises on Premenstrual Syndrome Symptoms: Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome, Exercises, Women Health"],"interventions":[{"type":"BEHAVIORAL","name":"Progressive Relaxation Exercises"}],"sponsor":"Kutahya Health Sciences University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":79,"enrollment_type":"ACTUAL","start_date":"2022-03-15","completion_date":"2022-12-30","first_posted":"2022-06-23","last_update":"2023-02-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05428800","reference_pmids":[],"brief_summary":"The aim of this study; to determine the effect of progressive relaxation exercises on premenstrual syndrome symptoms. The study is a randomized controlled trial, and women between the ages of 18-35 who meet the inclusion criteria will be included. Participant information form and premenstrual syndrome scale will be used in the research. There are two groups in the study as experimental (n=40) and control (n=40)."},
{"id":"NCT05327075","registry":"ClinicalTrials.gov","slug":"premenstrual-dysphoric-disorder-knowledge-attitude-and-nct05327075","match":"direct","title":"Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females","official_title":"Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females.Results of Surveying Two Centers in Delta Region","acronym":"PMDD","status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"OTHER","name":"questionnaire"}],"sponsor":"Al-Azhar University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":150,"enrollment_type":"ESTIMATED","start_date":"2022-03-15","completion_date":"2022-12","first_posted":"2022-04-14","last_update":"2022-07-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05327075","reference_pmids":[],"brief_summary":"it is a cross-sectional study conducted in female patients attending outpatient clinc in our university hospital to assess their awareness regarding the symptoms of premenstrual dysphoric disorders."},
{"id":"NCT05198115","registry":"ClinicalTrials.gov","slug":"premenstrual-syndrome-in-young-women-with-eight-weeks-of-nct05198115","match":"direct","title":"Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise","official_title":"Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Aerobic Exercise","Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"aerobic exercise"}],"sponsor":"Al-Azhar University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2022-02-25","completion_date":"2022-04-30","first_posted":"2022-01-20","last_update":"2022-02-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05198115","reference_pmids":[],"brief_summary":"The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome."},
{"id":"NCT05191108","registry":"ClinicalTrials.gov","slug":"premenstrual-syndrome-pms-and-mindfulness-stress-reduction-nct05191108","match":"direct","title":"Premenstrual Syndrome (PMS) and Mindfulness Stress Reduction Program (MSRP)","official_title":"The Effect of Mindfulness Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Study","acronym":"PMS and MSRP","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome"],"keywords":["mindfulness","premenstrual syndrome"],"interventions":[{"type":"BEHAVIORAL","name":"mindfulness stres reduction programe"}],"sponsor":"NURDİLAN SENER","sponsor_class":"OTHER","collaborators":["Kırklareli University"],"countries":["Turkey (Türkiye)"],"enrollment":74,"enrollment_type":"ACTUAL","start_date":"2022-02-21","completion_date":"2022-04-30","first_posted":"2022-01-13","last_update":"2022-06-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05191108","reference_pmids":["37335817"],"brief_summary":"Premenstrual syndrome (PMS) is a disorder characterized by emotional, physical and behavioral symptoms that increase the severity of the menstrual cycle in women of reproductive age during the luteal phase and disappear spontaneously a few days after the onset of menstruation. Nonpharmacological applications are often preferred to reduce premenstrual symptoms. It has been stated that with the meditation practices of mindfulness, individuals experience less anxiety, depression, anger and lower levels of psychological distress, including anxiety. . It is thought that the mindfulness stress reduction program can reduce the symptoms of PMS by regulating the stress level and emotional balance of women."},
{"id":"NCT05237661","registry":"ClinicalTrials.gov","slug":"study-to-evaluate-your-super-s-moon-balance-and-its-impact-nct05237661","match":"direct","title":"Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome","official_title":"Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["PMS","Menstrual Discomfort","Menstrual Pain"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Moon Balance"}],"sponsor":"Your Super, INC.","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":38,"enrollment_type":"ACTUAL","start_date":"2022-02-15","completion_date":"2022-05-31","first_posted":"2022-02-14","last_update":"2022-06-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05237661","reference_pmids":[],"brief_summary":"This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers."},
{"id":"NCT05697536","registry":"ClinicalTrials.gov","slug":"comparison-of-pilates-and-aerobic-exercises-on-pain-anxiety-nct05697536","match":"direct","title":"Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and QOL in PMS","official_title":"Comparison of Pilates and Aerobic Exercises on Pain, Anxiety and Quality of Life in Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Pilates training"},{"type":"OTHER","name":"Aerobic Exercise"}],"sponsor":"Riphah International University","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":26,"enrollment_type":"ACTUAL","start_date":"2022-01-15","completion_date":"2023-03-15","first_posted":"2023-01-26","last_update":"2023-06-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05697536","reference_pmids":["12725453","23983722","27807531","33246104"],"brief_summary":"The significance of this study is that it may improve the premenstrual symptoms like pain and anxiety in females with premenstrual syndrome and improve their quality of life. This study may add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy. Therefore, the study will be done to compare the effects of Pilate exercises and aerobic exercises on pain, anxiety and quality of life in females with premenstrual syndrome."},
{"id":"NCT05188456","registry":"ClinicalTrials.gov","slug":"the-impact-evaluation-of-the-covid-19-prevention-on-risk-nct05188456","match":"direct","title":"The Impact Evaluation of the COVID-19 Prevention on Risk Factors of HIV and Sexually Transmitted Comorbidity","official_title":"The Impact Evaluation of the COVID-19 Prevention Knowledge, Attitude, and Practice on Risk Factors of HIV and Sexually Transmitted Comorbidity: Application of Protection Motivation Theory","acronym":null,"status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["COVID-19 Pandemics","Human Immunodeficiency Virus"],"keywords":["Attitude","Behavior","Coronavirus disease 19 (COVID-19)","HIV high risk group","Knowledge","People living with HIV/AIDS (PLWHA)","Protection Motivation Theory (PMT)","Stigma"],"interventions":[],"sponsor":"National Taiwan University","sponsor_class":"OTHER","collaborators":["Ministry of Science and Technology, Taiwan"],"countries":["Taiwan"],"enrollment":2200,"enrollment_type":"ESTIMATED","start_date":"2022-01-13","completion_date":"2023-07-31","first_posted":"2022-01-12","last_update":"2023-04-24","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05188456","reference_pmids":[],"brief_summary":"This is a cross-sectional research. The Protection Motivation Theory (PMT) was applied as theoretical framework to analyze correlation of prevention knowledge, prevention intentions and anxiety, and prevention behavior of COVID-19 and HIV risk feature and behavior and stigma of people living with HIV/AIDS (PLWHA), and HIV high-risk groups. Purposive and snowball sampling will be applied to recruit participant who visit hospital, HIV/AIDS related institutions, and social media platforms. The investigators expect that the outcome could reveal the relationship of cognition and attitude of COVID-19 to HIV prevention and treatment."},
{"id":"NCT05290181","registry":"ClinicalTrials.gov","slug":"the-effect-of-pilates-exercise-and-whatsapp-text-based-nct05290181","match":"direct","title":"The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms","official_title":"The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms: A Randomized Controlled Study","acronym":"PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Physical Exercise","Women's Health"],"keywords":["Premenstrual Syndrome","Pilates exercises","Text message","women's health"],"interventions":[{"type":"OTHER","name":"A support program with pilates exercise and whatsapp text message"}],"sponsor":"Aydin Adnan Menderes University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":68,"enrollment_type":"ACTUAL","start_date":"2022-01-12","completion_date":"2022-06-05","first_posted":"2022-03-22","last_update":"2023-02-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05290181","reference_pmids":[],"brief_summary":"The aim of this study is to evaluate the effect of Pilates exercise and Whatsapp text message-based support program on PMS symptoms experienced by university female students."},
{"id":"NCT05145257","registry":"ClinicalTrials.gov","slug":"study-to-evaluate-the-efficacy-of-elix-s-cycle-balance-and-nct05145257","match":"direct","title":"Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms","official_title":"Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"OTHER","conditions":["PMS","Menstrual Pain"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Elix Cycle Balance"}],"sponsor":"Zenchi, Inc.","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":68,"enrollment_type":"ACTUAL","start_date":"2022-01-05","completion_date":"2022-05-31","first_posted":"2021-12-06","last_update":"2025-01-01","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT05145257?tab=results","url":"https://clinicaltrials.gov/study/NCT05145257","reference_pmids":[],"brief_summary":"This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms. It is hypothesized that the dietary supplement marketed as \"Elix Cycle Balance\" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as cramps, bloating, and mood swings. A total of 65 participants will be recruited for the trial following screening, with the expectation that at least 50 participants will complete the trial. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. The total intervention study period will be 3 months."},
{"id":"NCT06431646","registry":"ClinicalTrials.gov","slug":"effectiveness-of-web-based-education-on-premenstrual-nct06431646","match":"direct","title":"Effectiveness of Web-Based Education on Premenstrual Syndrome and Quality of Life","official_title":"Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms and Quality of Life","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Quality of Life"],"keywords":["Premenstrual Syndrome","Web-Based","Nurse-Led","Health Education","Quality of Life"],"interventions":[{"type":"BEHAVIORAL","name":"A web-based education intervention developed for university students with PMS"}],"sponsor":"Pamukkale University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":67,"enrollment_type":"ACTUAL","start_date":"2022-01-01","completion_date":"2022-06-13","first_posted":"2024-05-28","last_update":"2024-11-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06431646","reference_pmids":["22957993","27900828","31985138","32468669","34996424"],"brief_summary":"Digital solutions are becoming increasingly prevalent, addressing health concerns through innovative means has become imperative. Among these concerns, Premenstrual Syndrome (PMS) stands out as a significant challenge that affecting the physical and emotional well-being of women of reproductive age. Despite previous studies demonstrating the effectiveness of health education for PMS, there remains a gap in providing accessible and evidence-based interventions. The present study aims to fill this gap leveraging technology to deliver targeted information and support to women. For this reason, the purpose of this randomized controlled trial is to evaluate the effectiveness of a web-based health education in university students with PMS. The main questions it aims to answer are: * Does web-based education lower the premenstrual symptoms in university students with PMS? * Does web-based education improve the quality of life in university students with PMS? Researchers compared web-based education to a control (no special intervention) to see if intervention works to management PMS. Intervention group participants received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management strategies for 4 weeks."},
{"id":"NCT07337941","registry":"ClinicalTrials.gov","slug":"menstrual-cycle-phase-and-virtual-reality-on-preoperative-nct07337941","match":"related","title":"Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety","official_title":"The Effects of Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["American Society of Anesthesiologists (ASA) I-II Risk Groups","the Follicular (Days 1-12 From Last Menstruation) or Luteal (Days 20-24) Phase of the Menstrual Cycle","Aged 18-55"],"keywords":["Virtual Reality","Preoperative Anxiety","Menstrual Cycle Phase"],"interventions":[{"type":"OTHER","name":"15-minute video providing a visual and auditory experience (Training Video)"},{"type":"OTHER","name":"State-Trait Anxiety Inventory (STAI I-II)"},{"type":"OTHER","name":"The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment."}],"sponsor":"Zonguldak Bulent Ecevit University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":170,"enrollment_type":"ACTUAL","start_date":"2021-11-10","completion_date":"2022-02-10","first_posted":"2026-01-13","last_update":"2026-01-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07337941","reference_pmids":[],"brief_summary":"This study aims to examine the effects of menstrual cycle phase and a virtual reality (VR) intervention on preoperative anxiety in female patients scheduled for septorhinoplasty surgery."},
{"id":"NCT05264519","registry":"ClinicalTrials.gov","slug":"the-effect-of-foot-bath-on-pms-sleep-and-quality-of-life-nct05264519","match":"direct","title":"The Effect of Foot Bath on PMS, Sleep and Quality of Life Among University Students With PMS","official_title":"The Effect of Foot Bath on Premenstrual Syndrome, Sleep Quality and Quality of Life Among University Students With Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SCREENING","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Nursing","Foot Bath","Sleep Quality","Life Quality"],"interventions":[{"type":"OTHER","name":"foot bath intervention"}],"sponsor":"Hüsne YÜCESOY","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":77,"enrollment_type":"ACTUAL","start_date":"2021-11-06","completion_date":"2022-09-30","first_posted":"2022-03-03","last_update":"2024-12-11","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05264519","reference_pmids":[],"brief_summary":"Premenstrual syndrome is a cyclical disorder characterized by physical and emotional symptoms that appear in the late luteal phase of the menstrual cycle and subside within a few days with the onset of menstruation. Non-pharmacological methods should be recommended first to women who experience PMS symptoms. For this purpose, it is planned to apply foot bath to university students with premenstrual syndrome. The study was planned as a randomized controlled single-blind study. The universe of the research will be female students studying at Ordu University Faculty of Education in the 2021-2022 academic year. In the first stage of the study, female students who are 18 years of age and older and who voluntarily agree to participate in the research will be taken without making a sample selection. Considering the possibility of data loss during the research process, it was planned to work on 39 intervention and 39 control groups, including a total of 78 women In the collection of data; Personal Information Form, Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), SF-36 Quality of Life Scale will be used. PSQI and SF-36 Quality of Life Scale will be applied to students in the intervention group. The foot bath will be applied for 3 months, starting 7-10 days before the menstrual cycle, that is, in the luteal phase of the menstrual cycle. Students will be asked to fill out the Footbath Monitoring Form in order to assess whether they have taken a footbath. Those who apply foot bath at least 7 times will be included in the study. In case of less than seven students, the student will be excluded from the research and the new student who meets the criteria will be included in the research. At the end of each cycle, PMSÖ, PSQI and SF-36 will be administered to the students by the researcher. When the students in the Control Group are determined, PSQI and SF-36 will be applied by the researcher, and then PMSÖ, PSQI and SF-36 will be applied at the end of each cycle."},
{"id":"NCT04901598","registry":"ClinicalTrials.gov","slug":"physical-activity-level-aerobic-capacity-and-dietary-habits-nct04901598","match":"direct","title":"Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome","official_title":"Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome: an Observational Study","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["physical activity level, aerobic capacity and dietary habits in PMS"],"interventions":[{"type":"OTHER","name":"Running anaerobic sprint test and aerobic test"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2021-10-20","completion_date":"2022-03-25","first_posted":"2021-05-25","last_update":"2022-07-20","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04901598","reference_pmids":["22010771","27479626"],"brief_summary":"The aim of the study is to investigate the physical activity level, aerobic capacity and dietary habits among a cohort of females with premenstrual syndrome"},
{"id":"NCT06692946","registry":"ClinicalTrials.gov","slug":"clinical-efficacy-of-cooperative-parent-mediated-therapy-c-nct06692946","match":"direct","title":"Clinical Efficacy of Cooperative Parent-Mediated Therapy (C-PMT_in_ASD)","official_title":"Evaluation of the Clinical Efficacy of Cooperative Parent-Mediated Therapy (Cooperative-PMT) in Preschool and School-Aged Children With ASD Within the \"Autism in Re.Te: Let's Not Leave Them Alone\" - Social Project","acronym":"C-PMT in ASD","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Autism Spectrum Disorder","Parent-Training"],"keywords":["Neurodevelopmental disorders","Parent-child interaction","Community Healthcare service","Additional therapeutic effects"],"interventions":[{"type":"BEHAVIORAL","name":"Cooperative Parent-Mediated therapy"},{"type":"BEHAVIORAL","name":"Treatement as Usual"}],"sponsor":"ALESSANDRA CARTA","sponsor_class":"OTHER","collaborators":["Bambino Gesù Children's Hospital IRCCS"],"countries":["Italy"],"enrollment":50,"enrollment_type":"ACTUAL","start_date":"2021-09-01","completion_date":"2024-01-18","first_posted":"2024-11-18","last_update":"2024-11-18","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06692946","reference_pmids":["23633377","31549310","34283415","37898807"],"brief_summary":"The research highlights the lack of studies assessing the effectiveness of evidence-based interventions for ASD in community services. This RCT study aims to evaluate the effectiveness of Cooperative Parent Mediated Therapy (CPMT), a parent coaching program previously shown to be effective in tertiary care settings."},
{"id":"NCT04983017","registry":"ClinicalTrials.gov","slug":"2021-pmt-iage-intervention-trial-by-edifice-health-nct04983017","match":"direct","title":"2021 PMT iAge® Intervention Trial by Edifice Health","official_title":"Randomized, Double-Blinded, Placebo-Controlled Study With Immunotype Specific Dietary Supplements to Improve Inflammatory Age® by Edifice Health","acronym":null,"status":"TERMINATED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Chronic Inflammation","Inflammaging"],"keywords":["inflammatory age (iAge®)","immunosenescence","immune phenotyping","systemic chronic inflammation"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Dietary supplement"},{"type":"OTHER","name":"Placebo"}],"sponsor":"Edifice Health","sponsor_class":"INDUSTRY","collaborators":[],"countries":["United States"],"enrollment":781,"enrollment_type":"ACTUAL","start_date":"2021-08-10","completion_date":"2022-09-09","first_posted":"2021-07-30","last_update":"2024-09-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04983017","reference_pmids":["13688369","16466061","17872969","18776917","22028071","22108298","22198552","22254182","22646800","23331510","23945720","25661338","26244049","26589301","26840393","27727525","28801915","29213967","31270435","31352117","31504186","31803694","32330120","3397865"],"brief_summary":"This is a decentralized, double-blind, randomized, placebo-controlled study to assess the effectiveness of different dietary supplements in decreasing systemic chronic inflammation (SCI) and lowering inflammatory age (iAge®). iAge® is a metric for age-related chronic inflammation and immune function decline calculated from a standard blood draw utilizing immune phenotyping and artificial intelligence algorithms. SCI is a natural process that occurs within the body. It is believed to accelerate the process of biological aging. As opposed to acute inflammation, iAge® is not a reflection of illness, infection, trauma or injury. It naturally occurs in the ambulatory healthy population as we age as a function of the body. This study will use immunotype specific dietary supplement formulations to improve a participant's Inflammatory Age® (iAge®)."},
{"id":"NCT05019924","registry":"ClinicalTrials.gov","slug":"an-exploratory-investigation-of-dietary-supplementation-and-nct05019924","match":"direct","title":"An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms","official_title":"An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Menstrual Pain","Menstrual Discomfort"],"keywords":["PMS","Menstrual symptoms"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Semaine"}],"sponsor":"Semaine Health","sponsor_class":"INDUSTRY","collaborators":["Citruslabs"],"countries":["United States"],"enrollment":58,"enrollment_type":"ACTUAL","start_date":"2021-08-01","completion_date":"2021-11-30","first_posted":"2021-08-25","last_update":"2022-03-24","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05019924","reference_pmids":[],"brief_summary":"Dietary supplementation is widely used to alleviate various symptoms of PMS and menstruation such as bloating and cramping. Providing a combination of synergistic dietary supplements is hypothesized to significantly reduce self-reported PMS and menstrual discomfort when compared with a baseline without the intervention."},
{"id":"NCT05443477","registry":"ClinicalTrials.gov","slug":"hericium-erinaceus-mycelium-and-probiotic-of-the-grape-king-nct05443477","match":"direct","title":"Hericium Erinaceus Mycelium and Probiotic of the Grape King Bio on Symptoms of Premenstrual Syndrome","official_title":"To Evaluate the Improvement Effect of Supplementing Hericium Erinaceus Mycelium Capsules and Grape King Probiotic Capsules of the Grape King Bio on Physiological and Psychological Symptoms of Premenstrual Syndrome","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Hericium Erinaceus mycelium","probiotic"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Hericium Erinaceus Mycelium"},{"type":"DIETARY_SUPPLEMENT","name":"Probiotic"},{"type":"DIETARY_SUPPLEMENT","name":"control"}],"sponsor":"Chung Shan Medical University","sponsor_class":"OTHER","collaborators":[],"countries":["Taiwan"],"enrollment":105,"enrollment_type":"ESTIMATED","start_date":"2021-06-08","completion_date":"2023-01-07","first_posted":"2022-07-05","last_update":"2022-07-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05443477","reference_pmids":["16172836","20084389","20834180","32017837","32867260"],"brief_summary":"The purpose of this experiment is to evaluate the efficacy of supplemental health food Grape King Hericium erinaceus Mycelium Capsules and Grape King Probiotic Capsules in improving physical and psychological symptoms, blood oxidative stress and inflammation indicators in women with premenstrual syndrome."},
{"id":"NCT05811130","registry":"ClinicalTrials.gov","slug":"premenstrual-syndrome-and-its-influencing-factors-such-as-nct05811130","match":"direct","title":"Premenstrual Syndrome and Its Influencing Factors Such as Physical Activity, Perceived Stress and Mental Status","official_title":"Examinating Premenstrual Syndrome and Its Influencing Factors Such as Physical Activity, Perceived Stress and Mental Status - Cross Sectional Study","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["physical activity","perceived stress","mental health"],"interventions":[],"sponsor":"University of Pecs","sponsor_class":"OTHER","collaborators":[],"countries":["Hungary"],"enrollment":204,"enrollment_type":"ACTUAL","start_date":"2021-06-01","completion_date":"2021-12-31","first_posted":"2023-04-13","last_update":"2023-04-18","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05811130","reference_pmids":[],"brief_summary":"Our research aimed to investigate how a sedentary lifestyle, body mass index, depression, and stress affect the severity of PMS symptoms and how the listed factors influence each other."},
{"id":"NCT04806815","registry":"ClinicalTrials.gov","slug":"menstrual-cycle-induced-pain-fatigue-and-anxiety-in-women-nct04806815","match":"related","title":"Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19","official_title":"Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Menstrual Problem","Covid19","Fatigue"],"keywords":["Menstrual Problem","Covid19","Fatigue"],"interventions":[{"type":"OTHER","name":"A survey of 60 questions was created through the internet-based 'Google Forms surveys' site."}],"sponsor":"Biruni University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":180,"enrollment_type":"ACTUAL","start_date":"2021-05-18","completion_date":"2021-06-01","first_posted":"2021-03-19","last_update":"2021-06-30","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04806815","reference_pmids":[],"brief_summary":"The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. The aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19."},
{"id":"NCT04821232","registry":"ClinicalTrials.gov","slug":"does-yoga-done-to-women-with-premenstrual-syndrome-affect-nct04821232","match":"direct","title":"Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?","official_title":"Does Yoga Done To Women With Premenstrual Syndrome Affect Inflammation Parameters?: Single Blind, Randomized Controlled Trials","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Sendrom","yoga","midwifery student"],"interventions":[{"type":"OTHER","name":"yoga"},{"type":"OTHER","name":"Routin control"}],"sponsor":"Halic University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":36,"enrollment_type":"ESTIMATED","start_date":"2021-05-01","completion_date":"2021-09-01","first_posted":"2021-03-29","last_update":"2021-03-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04821232","reference_pmids":[],"brief_summary":"The menstrual cycle is one of the most important signs of a functioning reproductive system in women, but sometimes this cycle is associated with signs and symptoms that cause physical and psychological problems for women. Considering the high prevalence of PMS among women and the complications of this syndrome on work performance, social and interpersonal relationships and family, and its role in limiting education, social and economic progress in society, 8 weeks of online yoga exercises given online to female students were helpful in reducing PMS symptoms The aim was to evaluate the efficacy and effect on inflammation parameters. The study was planned as an interventional, single-blind, randomized controlled study. The sample size of this study was calculated based on the latest research available on the effect of exercise on PMS (Kamalifard et al.2017). A power analysis was performed in student PMS scores between exercise and control groups and to expect a difference of 80% strength and α = 0.50 and 30%. 80% power (1 - ß) minimum 18 students for each group, total 36 students will be included in the sample."},
{"id":"NCT04855981","registry":"ClinicalTrials.gov","slug":"whole-body-vibration-versus-aerobic-exercise-on-the-nct04855981","match":"direct","title":"Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome","official_title":"Effect of Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters in Females With Premenstrual Syndrome","acronym":"PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["whole body vibration","aerobic exercises","premenstrual syndrome"],"interventions":[{"type":"OTHER","name":"whole body vibration"},{"type":"OTHER","name":"aerobic exercise"},{"type":"OTHER","name":"supplementation"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":105,"enrollment_type":"ACTUAL","start_date":"2021-04-15","completion_date":"2022-05-30","first_posted":"2021-04-22","last_update":"2024-02-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04855981","reference_pmids":[],"brief_summary":"The purpose of this study is to investigate and compare the effect of whole-body vibration to aerobic exercise on inflammatory status in females with premenstrual syndrome."},
{"id":"NCT04955912","registry":"ClinicalTrials.gov","slug":"music-and-premenstrual-symptoms-and-quality-of-life-nct04955912","match":"direct","title":"Music and Premenstrual Symptoms and Quality of Life","official_title":"Effects of Music Medicine on Premenstrual Symptoms Levels and Quality of Life: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["MUSIC THERAPY","Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","music medicine","quality life","midwife","nurse"],"interventions":[{"type":"OTHER","name":"music medicine"}],"sponsor":"Kırklareli University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":89,"enrollment_type":"ACTUAL","start_date":"2021-01-30","completion_date":"2021-04-30","first_posted":"2021-07-09","last_update":"2021-07-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04955912","reference_pmids":[],"brief_summary":"Premenstrual syndrome is an important health problem affecting women of childbearing age. This study is a prospective, single-blinded randomized controlled trial. Participants were randomized into music, and control groups. Immediately post-intervention, the women in the experimental groups had significantly higher reduce premenstraul syndrome levels and increase a quality life."},
{"id":"NCT05349344","registry":"ClinicalTrials.gov","slug":"effect-of-aerobic-exercise-on-premenstrual-syndrome-symptoms-nct05349344","match":"direct","title":"Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).","official_title":"Effect of Aerobic Exercise Training on Premenstrual Syndrome Symptoms and Health Related Quality of Life Among Working Women","acronym":"PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Quality of Life"],"keywords":["Aerobic Training"],"interventions":[{"type":"OTHER","name":"Aerobic circuit training"},{"type":"OTHER","name":"Outdoor walk"}],"sponsor":"Riphah International University","sponsor_class":"OTHER","collaborators":[],"countries":["Pakistan"],"enrollment":50,"enrollment_type":"ACTUAL","start_date":"2020-09-20","completion_date":"2021-08-01","first_posted":"2022-04-27","last_update":"2022-04-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05349344","reference_pmids":["25279689","29350276"],"brief_summary":"To Determine the Effect of Regular Aerobic Exercise Training on Severity of Premenstrual Syndrome Symptoms and Health-Related Quality of life on working women.Exercise can be used as an alternative therapy in reducing premenstrual symptoms.But still there is lack of Literature on PMS in work Place and effect of Treatments to improve overall Quality of life in working women.And this study aims to fill the gap by assessing the impact that Premenstrual Syndrome can have on working women's Quality of life and can be used to establish a model of regular exercise program with the potential to decrease premenstrual symptoms and improve quality of life for a menstrual health-friendly workplace environment for Female Employees."},
{"id":"NCT04455685","registry":"ClinicalTrials.gov","slug":"prevalence-of-self-reported-premenstrual-syndrome-and-nct04455685","match":"direct","title":"Prevalence of Self-reported Premenstrual Syndrome and Analysis of Somatic and Psychoemotional Symptoms","official_title":"Prevalence of Self-reported Premenstrual Syndrome and Analysis of Somatic and Psychoemotional Symptoms in Brazilian Women Aged 20 to 49 Years","acronym":"LB2007","status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"anonymised data collection"}],"sponsor":"Libbs Farmacêutica LTDA","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Brazil"],"enrollment":1022,"enrollment_type":"ACTUAL","start_date":"2020-06-29","completion_date":"2020-06-29","first_posted":"2020-07-02","last_update":"2020-07-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04455685","reference_pmids":[],"brief_summary":"In Brazil there are few published studies that study, the prevalence, symptoms and the population's knowledge about the premenstrual syndrome of women of reproductive age, and that correlate these data with the sociodemographic conditions of these women. In addition, given the complexity of the diagnosis of PMS, the prevalence of PMS in the Brazilian female population may be lower than the self-reported and published in these works, since not all women who believe they suffer from PMS fully comply with the criteria contemplated in the consensus for diagnosis of PMS. In this sense, this study aims to analyze the prevalence and intensity of frequent symptoms of PMS reported by the Brazilian female population. The information generated with this study may help to rethink behaviors to improve the health and quality of life of these women, as well as offer tools for decision making related to the need for early and effective treatment of PMS, whose disorders are associated with both the fall present and future quality of life for women, as well as all of their family, social and professional coexistence."},
{"id":"NCT04838691","registry":"ClinicalTrials.gov","slug":"premenstrual-syndrome-and-interpersonal-counseling-nct04838691","match":"direct","title":"Premenstrual Syndrome and Interpersonal Counseling","official_title":"The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome"],"keywords":["premenstrual syndrome","interpersonal counseling"],"interventions":[{"type":"BEHAVIORAL","name":"interpersonal counseling"}],"sponsor":"Istanbul University - Cerrahpasa","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":80,"enrollment_type":"ACTUAL","start_date":"2020-04-06","completion_date":"2020-08-30","first_posted":"2021-04-09","last_update":"2021-04-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04838691","reference_pmids":[],"brief_summary":"This study aims to test the effectiveness of interpersonal counseling in PMS symptom management in university students experiencing PMS symptoms."},
{"id":"NCT03970200","registry":"ClinicalTrials.gov","slug":"penn-microbiome-therapy-pmt-for-severe-clostridium-difficile-nct03970200","match":"direct","title":"Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)","official_title":"A Phase II, Randomized Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Severe or Severe-Complicated/Fulminant Clostridium Difficile Infection","acronym":null,"status":"TERMINATED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Severe Clostridium Difficile Infection","Severe-Complicated/Fulminant Clostridium Difficile Infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"Penn Microbiome Therapy - 001"},{"type":"DRUG","name":"Penn Microbiome Therapy - 002"},{"type":"DRUG","name":"Penn Microbiome Therapy - 003"},{"type":"DRUG","name":"Antibiotics"}],"sponsor":"University of Pennsylvania","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":15,"enrollment_type":"ACTUAL","start_date":"2020-01-16","completion_date":"2022-05-14","first_posted":"2019-05-31","last_update":"2023-10-30","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT03970200?tab=results","url":"https://clinicaltrials.gov/study/NCT03970200","reference_pmids":[],"brief_summary":"This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff)."},
{"id":"NCT04086316","registry":"ClinicalTrials.gov","slug":"depressive-symptoms-and-subjective-stress-in-the-course-of-nct04086316","match":"related","title":"Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study.","official_title":"Vulnerable and Resilient Phases During the Menstrual Cycle and Their Influence on Depressive Symptoms and Stress. An Ambulatory Assessment Study on Healthy Women and Women With Depression.","acronym":"DepCy","status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Major Depressive Episode"],"keywords":["Menstrual Cycle","Major Depressive Disorder","Stress","Sex hormones","Depression","Female","Ambulatory Assessment"],"interventions":[],"sponsor":"Freie Universität Berlin","sponsor_class":"OTHER","collaborators":[],"countries":["Germany"],"enrollment":77,"enrollment_type":"ACTUAL","start_date":"2020-01-15","completion_date":"2022-12-30","first_posted":"2019-09-11","last_update":"2023-02-17","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04086316","reference_pmids":["39551735"],"brief_summary":"Background: Major changes in female sex hormone concentrations influence the development of depressive symptoms in women. This hypothesis has been thoroughly investigated with regard to the menopause, the postpartal phase and also premenstrual dysphoric disorder. However, much less is known regarding the impact of female sex hormone fluctuations on depression during the regular menstrual cycle. There are indications that during the luteal phase, women might be more vulnerable to the development of depressive symptoms, while during the follicular phase and at ovulation, hormone concentrations might present a protective factor against depressive symptomatology. Subjective stress could mediate the relationship between depressive symptom development and the menstrual cycle phases. The complex interaction between sex hormones and psychological symptoms in the course of menstrual cycle phases is still understudied. Method: 74 women (37 with and 37 without current depressive episode), will take part in a smartphone-based ambulatory assessment. Women will provide daily ratings of depressive symptoms and perceived stress for a period of one menstrual cycle (approx. 26-30 days). Three menstrual cycle phases will be assessed - the follicular phase, ovulation and the luteal phase. An ambulatory assessment will be used for these daily assessments. To assess the menstrual cycle phase participants will use ovulation tests on five days in the late follicular phase. The following research questions will be investigated: Research question 1: Do depressive symptoms (number and severity) change in the course of the menstrual cycle within the two groups? Research question 2: Which depressive symptoms are particularly sensitive to changes in the course of the menstrual cycle phases? Research question 3: Does the subjective stress change in the course of the menstrual cycle within the two groups? Research question 4: Are there differences between depressive and healthy women in terms of changes in depressive symptoms and subjective stress experience? Implications: The aim of the study is to investigate women-specific psychobiological factors influencing depression. Therefore, fluctuations in depressive symptoms and subjective stress experience will be investigated as a function of the respective menstrual cycle phases. The identification of cycle phases associated with increased or reduced vulnerability to depressive symptoms will support the development of women-specific prevention and treatment programs."},
{"id":"NCT04123483","registry":"ClinicalTrials.gov","slug":"enbrace-hr-for-pms-with-prominent-mood-symptoms-or-menstrual-nct04123483","match":"direct","title":"EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders","official_title":"EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)","acronym":null,"status":"WITHDRAWN","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Premenstrual Dysphoric Disorder","Premenstrual Tension","Menstrual Related Mood Disorder"],"keywords":["PMS","Folate","Omega-3 Fatty Acids","Vitamins","Women's Health","Dietary Supplements","PMDD","MRMD","Menstrual Related Mood Disorder","Premenstrual Tension"],"interventions":[{"type":"DRUG","name":"EnBrace HR Softgel"}],"sponsor":"Massachusetts General Hospital","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":0,"enrollment_type":"ACTUAL","start_date":"2019-11","completion_date":"2022-11","first_posted":"2019-10-11","last_update":"2020-01-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04123483","reference_pmids":[],"brief_summary":"The purpose of this study is to assess a novel nutritional supplement developed for prenatal health and mood benefits, and to determine whether there is preliminary evidence for efficacy in Menstrual Related Mood Disorders (MRMD), including PMS with Prominent Mood Symptoms and PMDD."},
{"id":"NCT03862469","registry":"ClinicalTrials.gov","slug":"premenstrual-hormonal-and-affective-state-evaluation-phase-nct03862469","match":"direct","title":"Premenstrual Hormonal and Affective State Evaluation (PHASE) Project","official_title":"Premenstrual Hormonal and Affective State Evaluation (PHASE) Project","acronym":"PHASE Project","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"PREVENTION","conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Individualized laboratory test"}],"sponsor":"University of Illinois at Chicago","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":129,"enrollment_type":"ACTUAL","start_date":"2019-09-26","completion_date":"2023-09-01","first_posted":"2019-03-05","last_update":"2025-04-24","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT03862469?tab=results","url":"https://clinicaltrials.gov/study/NCT03862469","reference_pmids":["10940144","11681764","16172836","16650465","16651505","18644678","18974081","19373620","20053272","20176450","21035130","22029804","22377229","22450372","23277355","28229114","28273494","29146473","29180346","29260367","38664491","6686333","8255414","9435325"],"brief_summary":"PHASE is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe PMS (i.e., premenstrual dysphoric disorder)."},
{"id":"NCT04202432","registry":"ClinicalTrials.gov","slug":"clinical-validation-of-algorithms-for-mean-systemic-filling-nct04202432","match":"direct","title":"Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output","official_title":"PP3D - Prospective Combined Validation of an Algorithm for Measurement of Mean Systemic Filling Pressure and Comparison of Invasively Measured Cardiac Output Versus Cardiac Output Calculated by 3D TOE and Carotid Ultrasound.","acronym":"PP3D","status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Shock, Cardiogenic","Shock Hypovolemic","Hypovolemia","Cardiac Failure"],"keywords":["Mean Systemic Filling Pressure","Pms","Pmsf","Hypovolemia","Cardiac Output","Transpulmonary thermodilution","Transesophageal echocardiography","Volume state","Critical Care","Cardiosurgery","Intensive Care","Carotid ultrasound","Pulsed Wave","Inspiratory breath hold"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Mean systemic filling pressure"}],"sponsor":"Catharina Ziekenhuis Eindhoven","sponsor_class":"OTHER","collaborators":[],"countries":["Netherlands"],"enrollment":18,"enrollment_type":"ACTUAL","start_date":"2019-06-24","completion_date":"2019-08-30","first_posted":"2019-12-17","last_update":"2019-12-18","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04202432","reference_pmids":["33791920"],"brief_summary":"Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output."},
{"id":"NCT05144568","registry":"ClinicalTrials.gov","slug":"the-effect-of-nutrition-education-on-premenstrual-syndrome-nct05144568","match":"direct","title":"The Effect of Nutrition Education on Premenstrual Syndrome","official_title":"The Effect of Nutrition Education on Premenstrual Syndrome: Randomized Controlled Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["premenstrual syndrome","nutritional status","nutrition education","nursing students","university students"],"interventions":[{"type":"OTHER","name":"Nutrition education"}],"sponsor":"Ordu University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":83,"enrollment_type":"ACTUAL","start_date":"2019-06-03","completion_date":"2019-09-30","first_posted":"2021-12-03","last_update":"2021-12-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT05144568","reference_pmids":[],"brief_summary":"The aim of our study is to examine the effect of nutritional education given to university students with premenstrual syndrome (PMS) on premenstrual symptom severity, nutrient intake and anthropometric measures. Our hypothesis is that nutrition education reduces symptoms in students with PMS. The effect of nutrition education on premenstrual syndrome was evaluated. The sample for this study included 83 female students, with 43 in the experimental and 40 in the control group, who were studying at the health sciences faculty of a state university and met the inclusion criteria. Experimental and control groups were formed by randomized method. Nutrition training was given to the experimental group. Participant data were collected before and four months after nutrition training. The data were collected with the personal information form, Premenstrual Syndrome Scale and food consumption record form. Nutrient amounts were determined in the Nutrition Information System (BEBİS) program."},
{"id":"NCT04002713","registry":"ClinicalTrials.gov","slug":"comparison-of-choosing-free-alt-or-free-pmt-for-nct04002713","match":"direct","title":"Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer","official_title":"Comparison of the Outcome of Choosing Free Anterolateral Thigh or Free Posterolateral Thigh Flap for Reconstruction in Patients With Head and Neck Cancer","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Reconstructive Surgery","Head and Neck Cancer"],"keywords":["Anterolateral thigh (ALT)","anteromedial thigh (AMT)","free flap reconstruction","microsurgery","head and neck cancer","outcomes"],"interventions":[{"type":"OTHER","name":"ALT flap reconstruction"},{"type":"OTHER","name":"AMT flap reconstruction"}],"sponsor":"Chang Gung Memorial Hospital","sponsor_class":"OTHER","collaborators":[],"countries":["Taiwan"],"enrollment":1590,"enrollment_type":"ACTUAL","start_date":"2019-03-20","completion_date":"2019-06-03","first_posted":"2019-07-01","last_update":"2019-07-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04002713","reference_pmids":[],"brief_summary":"This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction."},
{"id":"NCT04618172","registry":"ClinicalTrials.gov","slug":"effects-of-exercise-on-the-symptoms-of-premenstrual-syndrome-nct04618172","match":"direct","title":"Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract","official_title":"Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Dysmenorrhoea"],"keywords":[],"interventions":[{"type":"OTHER","name":"Exercise"}],"sponsor":"Kovács Zoltán","sponsor_class":"OTHER","collaborators":[],"countries":["Hungary"],"enrollment":113,"enrollment_type":"ACTUAL","start_date":"2019-03-01","completion_date":"2020-06-30","first_posted":"2020-11-05","last_update":"2023-11-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04618172","reference_pmids":["38002635"],"brief_summary":"Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational trial. The study has interventional and control groups. There are changes in premenstrual syndrome complaints and dysmenorrhoea complaints during the study period.The deegre of menstrual pain and self-awareness improve during the period of study. The ultrasound examination shows changes in genital blood flow after exercise."},
{"id":"NCT04320641","registry":"ClinicalTrials.gov","slug":"the-effect-of-acupressure-and-yoga-on-premenstrual-symptoms-nct04320641","match":"direct","title":"The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life","official_title":"The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life in Coping With PMS","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"OTHER","conditions":["Premenstrual Syndrome","Nursing Caries"],"keywords":["PMS,","YOGA","NURSING","HEALTH QUALITY"],"interventions":[{"type":"OTHER","name":"ACUPRESSURE"}],"sponsor":"Adiyaman University Research Hospital","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":153,"enrollment_type":"ACTUAL","start_date":"2019-02-15","completion_date":"2020-01-10","first_posted":"2020-03-25","last_update":"2020-03-25","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04320641","reference_pmids":[],"brief_summary":"The research was carried out to determine the effect of acupressure and yoga applied to cope with PMS on premenstrual symptoms and quality of life."},
{"id":"NCT04296422","registry":"ClinicalTrials.gov","slug":"different-does-of-acupuncture-on-premenstrual-syndrome-nct04296422","match":"direct","title":"Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis","official_title":"Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Acupuncture","Premenstrual Syndrome","TCM syndrome"],"interventions":[{"type":"DRUG","name":"NSAIDs or oral contraceptives treatment"},{"type":"DEVICE","name":"Low dose acupuncture"},{"type":"DEVICE","name":"High dose acupuncture"}],"sponsor":"Taipei City Hospital","sponsor_class":"OTHER_GOV","collaborators":[],"countries":["Taiwan"],"enrollment":105,"enrollment_type":"ESTIMATED","start_date":"2019-01-01","completion_date":"2020-09-18","first_posted":"2020-03-05","last_update":"2020-03-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04296422","reference_pmids":[],"brief_summary":"The design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Serum marker change of PGE2, CA125, E2, and progesterone in enrolled patients will be measured before and after treatment, along with VAS and MDQ questionnaires. The treatment efficacy of different groups and the relationship between PMS and patients TCM syndrome pattern will also be recorded and estimated."},
{"id":"NCT03449979","registry":"ClinicalTrials.gov","slug":"single-session-of-tacs-in-a-depressive-episode-nct03449979","match":"direct","title":"Single Session of tACS in a Depressive Episode","official_title":"Rational Optimization of tACS for Targeting Thalamo-Cortical Oscillations (Experiment 3)","acronym":"SSDE","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Depression","Major Depressive Disorder","Premenstrual Dysphoric Disorder","Depressive Episode"],"keywords":["tACS","transcranial alternating current stimulation","stimulation","heart rate variability","electroencephalogram","EEG"],"interventions":[{"type":"DEVICE","name":"XCSITE100 Stimulator Sham"},{"type":"DEVICE","name":"XCSITE100 Stimulator tACS"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":84,"enrollment_type":"ACTUAL","start_date":"2018-09-19","completion_date":"2019-08-16","first_posted":"2018-02-28","last_update":"2020-06-04","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT03449979?tab=results","url":"https://clinicaltrials.gov/study/NCT03449979","reference_pmids":[],"brief_summary":"Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders. Participants: 40 males and females, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric conditions. Procedures: This is a single visit study with two stimulation conditions (tACS and sham tACS). The session will begin with clinical assessments (including confirmation of diagnosis), followed by an interactive EEG task, then a 7 minute resting state EEG (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes of tACS or sham tACS), followed by an additional 5 minute resting state EEG. The stimulation will involved 40 minutes of transcranial alternating current stimulation, 2 mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz)."},
{"id":"NCT03708679","registry":"ClinicalTrials.gov","slug":"effects-of-menstrual-cycle-on-preoperative-anxiety-nct03708679","match":"related","title":"Effects of Menstrual Cycle on Preoperative Anxiety","official_title":"Are Menstruel Cycle Phases Effective on Preoperative Anxiety? Prospective, Clinical Study","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Menstrual Cycle","Perioperative Hypertension","Anxiety"],"keywords":[],"interventions":[],"sponsor":"Yuzuncu Yil University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2018-09-15","completion_date":"2018-12-20","first_posted":"2018-10-17","last_update":"2019-01-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03708679","reference_pmids":[],"brief_summary":"The investigators aimed to investigate the effect of menstrual cycle phases on preoperative anxiety in women under general anesthesia."},
{"id":"NCT03547661","registry":"ClinicalTrials.gov","slug":"open-label-placebo-treatment-of-women-with-premenstrual-nct03547661","match":"direct","title":"Open-Label Placebo Treatment of Women With Premenstrual Syndrome","official_title":"Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial","acronym":"OLPPMS_1","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome","Open-Label Placebo Effect","randomized controlled trial"],"interventions":[{"type":"OTHER","name":"P-Dragees rosa Lichtenstein"}],"sponsor":"Jens Gaab","sponsor_class":"OTHER","collaborators":[],"countries":["Switzerland"],"enrollment":150,"enrollment_type":"ACTUAL","start_date":"2018-08-02","completion_date":"2021-06-28","first_posted":"2018-06-06","last_update":"2025-06-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03547661","reference_pmids":["16001107","18171451","18395582","21203519","24401940","26352222","27744433","27755279","32071176","385093","40132912"],"brief_summary":"This study aims to investigate the effect of an open-label placebo intervention on premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be randomly allocated to three groups: to a treatment as usual group, an open-label placebo group, and an integrative open-label placebo group. Participants of all groups will conclude a prospective PMS screening for one menstrual cycle. Thereafter, participants of both intervention groups will obtain an openly administered placebo intervention for six weeks. Participants of the treatment as usual group will have the chance to obtain the same open-label placebo intervention after study conduct. Diverse measures will be assessed by means of a PMS symptom diary and questionnaires. Furthermore, we assess participants experiences of study participation qualitatively by means of semi-structured interviews."},
{"id":"NCT03498313","registry":"ClinicalTrials.gov","slug":"unique-effects-of-perimenstrual-estradiol-or-progesterone-nct03498313","match":"direct","title":"Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality","official_title":"Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality","acronym":"CLEAR-2","status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Suicidal Ideation"],"keywords":["steroid hormones","estradiol","estrogen","progesterone","depression","suicide"],"interventions":[{"type":"DRUG","name":"Transdermal Estradiol + Placebo"},{"type":"DRUG","name":"Oral Micronized Progesterone + Placebo"},{"type":"DRUG","name":"Placebos"}],"sponsor":"University of Illinois at Chicago","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"2018-07-27","completion_date":"2021-05-09","first_posted":"2018-04-13","last_update":"2022-09-14","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT03498313?tab=results","url":"https://clinicaltrials.gov/study/NCT03498313","reference_pmids":["41913970"],"brief_summary":"This within-person, crossover, 3-condition, placebo-controlled study compares the impact of three perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The three conditions are (1) perimenstrual withdrawal from estradiol only (during progesterone stabilization), (2) perimenstrual withdrawal from progesterone only (during estradiol stabilization), and (3) perimenstrual withdrawal from both estradiol and progesterone during placebo."},
{"id":"NCT03529721","registry":"ClinicalTrials.gov","slug":"effect-of-zumba-dance-on-premenstrual-tension-nct03529721","match":"direct","title":"Effect of Zumba Dance on Premenstrual Tension","official_title":"Effect of Zumba Dance on Premenstrual Tension:8 Weeks Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Tension"],"keywords":[],"interventions":[{"type":"OTHER","name":"zumba dance fitness"},{"type":"OTHER","name":"non zumba dance"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2018-06-20","completion_date":"2019-05-01","first_posted":"2018-05-18","last_update":"2019-06-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03529721","reference_pmids":[],"brief_summary":"Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report will be filled at the start and at end of the study (before and after performing swimming exercise) Females in group I will be instructed to engage into 12 classes of 60-minute Zumba® fitness over an 8-week period."},
{"id":"NCT03881319","registry":"ClinicalTrials.gov","slug":"the-efficacy-of-different-doses-of-acupuncture-in-nct03881319","match":"direct","title":"The Efficacy of Different Doses of Acupuncture in Dysmenorrhea","official_title":"The Study of Efficacy and Effect of Different Dose Acupuncture on Autonomic Nervous Activity and Quality of Life in Women With Dysmenorrhea","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Dysmenorrhea"],"keywords":["Acupuncture","Premenstrual Syndrome","Dysmenorrhea","Autonomic nervous activity","TCM syndrome","Meridian"],"interventions":[{"type":"DRUG","name":"Conventional gynecologic treatment"},{"type":"DEVICE","name":"Low dose acupuncture"},{"type":"DEVICE","name":"High dose acupuncture"}],"sponsor":"Taipei City Hospital","sponsor_class":"OTHER_GOV","collaborators":[],"countries":["Taiwan"],"enrollment":105,"enrollment_type":"ESTIMATED","start_date":"2018-06-01","completion_date":"2019-12-31","first_posted":"2019-03-19","last_update":"2019-03-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03881319","reference_pmids":[],"brief_summary":"Subjects in this study included premenstrual syndrome and dysmenorrhea. Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus. In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few. Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?"},
{"id":"NCT03697265","registry":"ClinicalTrials.gov","slug":"a-study-of-efficacy-and-safety-of-sepranolone-uc1010-in-nct03697265","match":"direct","title":"A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)","official_title":"A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Sepranolone (UC1010) low dose"},{"type":"DRUG","name":"Sepranolone (UC1010) high dose"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Asarina Pharma","sponsor_class":"INDUSTRY","collaborators":["Ergomed"],"countries":["Germany","Poland","Sweden","United Kingdom"],"enrollment":475,"enrollment_type":"ACTUAL","start_date":"2018-04-20","completion_date":"2020-10-23","first_posted":"2018-10-05","last_update":"2020-10-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03697265","reference_pmids":["28319848"],"brief_summary":"The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid."},
{"id":"ISRCTN14743304","registry":"ISRCTN","slug":"validation-of-prementrics-smartphone-app-patient-and-isrctn14743304","match":"direct","title":"Validation of PreMentricS smartphone app: patient and clinician acceptability of using an electronic method for measuring premenstrual symptoms","official_title":"Validation of PreMentricS smartphone app: patient and clinician acceptability of using an electronic method for premenstrual symptom quantification","acronym":null,"status":"NO_LONGER_RECRUITING","phases":[],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual disorders"],"keywords":["Signs and Symptoms"],"interventions":[{"type":"Other","name":null}],"sponsor":"University of Alberta","sponsor_class":null,"collaborators":[],"countries":["Australia","Canada","France","India","United Kingdom","United States of America"],"enrollment":115,"enrollment_type":"ACTUAL","start_date":"2018-03-18","completion_date":"2019-05-30","first_posted":"2018-06-14","last_update":null,"has_results":false,"results_url":null,"url":"https://www.isrctn.com/ISRCTN14743304","reference_pmids":[],"brief_summary":null},
{"id":"NCT07791121","registry":"ClinicalTrials.gov","slug":"progressive-muscle-relaxation-and-kinesio-taping-for-nct07791121","match":"direct","title":"Progressive Muscle Relaxation and Kinesio Taping for Premenstrual Syndrome","official_title":"The Effects of Progressive Muscle Relaxation Exercise and Kinesio Taping on Stress, Depression, and Sleep Quality in University Students With Premenstrual Syndrome: A Randomized Controlled Trial","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Progressive Muscle Relaxation","Kinesio Taping","Premenstrual Symptoms","Perceived Stress","Depressive Symptoms","Sleep Quality","University Students"],"interventions":[{"type":"BEHAVIORAL","name":"Progressive Muscle Relaxation Exercise"},{"type":"DEVICE","name":"Kinesio Taping"}],"sponsor":"ASLI ER KORUCU","sponsor_class":"OTHER","collaborators":["Hacettepe University"],"countries":["Turkey (Türkiye)"],"enrollment":194,"enrollment_type":"ACTUAL","start_date":"2017-12-11","completion_date":"2018-08-02","first_posted":"2026-08-27","last_update":"2026-08-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT07791121","reference_pmids":[],"brief_summary":"This randomized controlled trial evaluated the effects of progressive muscle relaxation exercise, kinesio taping, and their combined application on premenstrual symptoms, perceived stress, severity of depressive symptoms, and sleep quality among university students with premenstrual syndrome. Participants were randomly assigned to progressive muscle relaxation, kinesio taping, combined progressive muscle relaxation and kinesio taping, or a control group. The interventions were implemented for 8 weeks. Outcomes were assessed at baseline, immediately after the intervention, and 1 month after completion of the intervention."},
{"id":"NCT03298607","registry":"ClinicalTrials.gov","slug":"the-impact-of-serelys-pms-on-symptoms-of-pms-nct03298607","match":"direct","title":"The Impact of Serelys PMS on Symptoms of PMS","official_title":"The Impact of Sérélys PMS, a Herbal Remedy Based on Pollen Extraction and Saffron, on Symptoms of PMS: A Randomized, Double-blinded, Placebo Controlled Study","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Placebo"},{"type":"DIETARY_SUPPLEMENT","name":"Serelys PMS"}],"sponsor":"Jens Rikardt Andersen","sponsor_class":"OTHER","collaborators":["Serelys Pharma"],"countries":["Denmark"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"2017-10-30","completion_date":"2018-06-01","first_posted":"2017-10-02","last_update":"2018-10-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03298607","reference_pmids":[],"brief_summary":"The objective of the present study is to better define and evaluate Serelys PMS in terms of the impact on the different premenstrual syndrome (PMS) symptoms , tolerance, satisfaction and overall quality of life of women with known discomforts during the premenstrual period. The data from this study will be compared to data when the two different ingredients are given as monotherapy."},
{"id":"NCT03899207","registry":"ClinicalTrials.gov","slug":"acupressure-and-training-for-coping-with-pms-nct03899207","match":"direct","title":"Acupressure and Training for Coping With PMS","official_title":"Adiyaman University School of Health","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"SUPPORTIVE_CARE","conditions":["Premenstrual Syndrome","Acupressure"],"keywords":[],"interventions":[{"type":"OTHER","name":"training +acupressure"},{"type":"OTHER","name":"training"}],"sponsor":"Adiyaman University Research Hospital","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":199,"enrollment_type":"ACTUAL","start_date":"2017-06-30","completion_date":"2018-04-20","first_posted":"2019-04-02","last_update":"2019-08-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03899207","reference_pmids":[],"brief_summary":"The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life. This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest."},
{"id":"NCT03122457","registry":"ClinicalTrials.gov","slug":"perimenstrual-acne-with-clindamycin-phosphate-and-benzoyl-nct03122457","match":"direct","title":"Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide","official_title":"Improvement of Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide 1.2%/3.75% Combination Gel","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Actinic Keratosis"],"keywords":["Actinic Keratosis"],"interventions":[{"type":"DRUG","name":"lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination"}],"sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_class":"OTHER","collaborators":["Bausch Health Americas, Inc."],"countries":["United States"],"enrollment":22,"enrollment_type":"ACTUAL","start_date":"2017-01-01","completion_date":"2018-07-19","first_posted":"2017-04-20","last_update":"2020-09-04","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT03122457?tab=results","url":"https://clinicaltrials.gov/study/NCT03122457","reference_pmids":[],"brief_summary":"The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne. Eligible women will be over the age of 18 and not on any current therapy. The patients will first arrive for a screening visit, where they will be given questionnaires on acne quality of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of menses (as studies indicate that most women have their acne flare during this time). The study team will perform a zit count (counting papules, pustules, and comedones) and global assessment, and the patient will be instructed to record their menses (which they will do for the duration of the study). The patients will then return in 2 weeks, at day 15, and they will be re-assessed. The patients will be dispensed the investigational product and instructed on its daily use. The patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study). The duration of the study per patient is approximately 4 months, and the study team anticipates an enrollment period of 12 months."},
{"id":"NCT03720847","registry":"ClinicalTrials.gov","slug":"effect-of-perimenstrual-ovarian-steroid-supplementation-on-nct03720847","match":"direct","title":"Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality","official_title":"Ovarian Hormone Withdrawal and Suicide Risk: An Experimental Approach","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Suicidal Ideation"],"keywords":["Steroid hormones","Estradiol","Progesterone","Depression","Suicide"],"interventions":[{"type":"DRUG","name":"Estradiol Transdermal Patch 0.1 mg/24 hrs"},{"type":"DRUG","name":"Oral Micronized Progesterone"},{"type":"DRUG","name":"Inactive Clear Patch"},{"type":"DRUG","name":"Placebo capsule"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":30,"enrollment_type":"ACTUAL","start_date":"2016-12-31","completion_date":"2017-11","first_posted":"2018-10-25","last_update":"2019-02-04","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT03720847?tab=results","url":"https://clinicaltrials.gov/study/NCT03720847","reference_pmids":["36585408","37326562","37611527"],"brief_summary":"This within-person, crossover, 2-condition, placebo-controlled study compares the impact of two perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) natural perimenstrual withdrawal from estradiol and progesterone (during placebo), (2) perimenstrual stabilization of estradiol and progesterone using transdermal estradiol and oral micronized progesterone."},
{"id":"NCT03509714","registry":"ClinicalTrials.gov","slug":"oxaloacetate-supplementation-for-emotional-pms-nct03509714","match":"direct","title":"Oxaloacetate Supplementation for Emotional PMS","official_title":"Oxaloacetate Supplementation for Emotional PMS; Measuring Improvements in Depression, Anxiety, Perceived Stress, and Aggression","acronym":"OAA4PMS","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome (PMS)"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)"},{"type":"DIETARY_SUPPLEMENT","name":"rice flour (Placebo)"}],"sponsor":"Terra Biological LLC","sponsor_class":"INDUSTRY","collaborators":[],"countries":[],"enrollment":48,"enrollment_type":"ACTUAL","start_date":"2016-10-17","completion_date":"2017-09-01","first_posted":"2018-04-26","last_update":"2018-04-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03509714","reference_pmids":["19793063","20821056","21092938","25027327","32206660","4884771"],"brief_summary":"Emotional Premenstrual Syndrome (PMS) affects millions of women worldwide. For Emotional PMS, including depression, anxiety, perceived stress and aggression, there are very few options. Recent observational data suggest that nutritional supplementation with oxaloacetate, a human energy metabolite, greatly reduced the symptoms of Emotional PMS. The aim of this study was to confirm these observations on the effects of oxaloacetate on Emotional PMS symptom severity within a controlled clinical trial setting."},
{"id":"NCT03264612","registry":"ClinicalTrials.gov","slug":"effect-of-swimming-on-premenstrual-syndrome-nct03264612","match":"direct","title":"Effect of Swimming on Premenstrual Syndrome","official_title":"Effect of Aeropbic Exercise as Swimming on Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Aerobic exercise"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":70,"enrollment_type":"ACTUAL","start_date":"2016-04-03","completion_date":"2017-08-12","first_posted":"2017-08-29","last_update":"2017-08-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT03264612","reference_pmids":["29350276"],"brief_summary":"Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down."},
{"id":"NCT02777372","registry":"ClinicalTrials.gov","slug":"stress-premenstrual-symptoms-study-nct02777372","match":"direct","title":"Stress & Premenstrual Symptoms Study","official_title":"Psychophysiology, Neurosteroids, and Stress in Premenstrual Dysphoric Disorder","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["PMDD","Stress","Mood"],"keywords":["Zoloft","premenstrual syndrome (PMS)","Menses"],"interventions":[{"type":"DRUG","name":"Sertraline"}],"sponsor":"Johns Hopkins University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":84,"enrollment_type":"ACTUAL","start_date":"2016-04-01","completion_date":"2021-12-01","first_posted":"2016-05-19","last_update":"2025-06-12","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT02777372?tab=results","url":"https://clinicaltrials.gov/study/NCT02777372","reference_pmids":["17314917","26377947","28041003","29777410","32435664","34292344","38091917","39096755"],"brief_summary":"This study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs) at baseline and after treatment with sertraline. Participants will include women with PMDs and healthy female controls. Participation involves a baseline visit to determine eligibility and three study visits that include questionnaires and stress reactivity assessment via an acoustic startle paradigm. Female participants with PMDs will receive sertraline during the premenstrual phase."},
{"id":"NCT01217775","registry":"ClinicalTrials.gov","slug":"intranasal-ph80-spray-for-acute-management-of-the-symptoms-nct01217775","match":"direct","title":"Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder","official_title":"A Phase 3 Study of the Use of PH80 for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder","acronym":"PH80-PMD","status":"UNKNOWN","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["PMDD, Premenstrual, Dysphoria, Mood Swings, Bloating."],"interventions":[{"type":"DRUG","name":"PH80"},{"type":"DRUG","name":"Placebo intranasal spray"}],"sponsor":"Pherin Pharmaceuticals, Inc.","sponsor_class":"INDUSTRY","collaborators":[],"countries":["United States"],"enrollment":1400,"enrollment_type":"ESTIMATED","start_date":"2016-03","completion_date":"2017-07","first_posted":"2010-10-08","last_update":"2015-12-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01217775","reference_pmids":[],"brief_summary":"The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms in women who regularly experience premenstrual dysphoric disorder (PMDD)."},
{"id":"NCT02355171","registry":"ClinicalTrials.gov","slug":"personalize-my-treatment-pmt-registry-nct02355171","match":"direct","title":"Personalize My Treatment (PMT) Registry","official_title":"A Large-scale Longitudinal Oncology Registry","acronym":"PMT","status":"SUSPENDED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Cancer"],"keywords":[],"interventions":[],"sponsor":"Exactis Innovation","sponsor_class":"OTHER","collaborators":[],"countries":["Canada"],"enrollment":10000,"enrollment_type":"ESTIMATED","start_date":"2015-11","completion_date":"2024-12-13","first_posted":"2015-02-04","last_update":"2025-02-04","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02355171","reference_pmids":[],"brief_summary":"The 'Personalize My treatment' (PMT) platform is a novel form of biobanking in which cancer patients willingly consent to provide residual, clinical samples (surplus after diagnostic testing) of their tumors for cancer research, to give access to their medical record for data collection and then followed prospectively throughout the trajectory of their illness. They further willingly consent to be recontacted for being informed of other research projects, including clinical trials."},
{"id":"NCT02562053","registry":"ClinicalTrials.gov","slug":"does-adding-oral-contraceptives-to-fluoxetine-improve-the-nct02562053","match":"direct","title":"Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?","official_title":"Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.","acronym":null,"status":"UNKNOWN","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Fluoxetine"},{"type":"DRUG","name":"Combined oral contraceptives"},{"type":"DRUG","name":"Placebo 1"},{"type":"DRUG","name":"Placebo 2"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":300,"enrollment_type":"ESTIMATED","start_date":"2015-10","completion_date":"2017-09","first_posted":"2015-09-29","last_update":"2016-07-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02562053","reference_pmids":["12715267","15508358","22336820","23744611"],"brief_summary":"Three hundred women with severe premenstrual syndrome will be divided into 3 groups using computer generated random numbers. Group 1 will receiveCombined oral contraceptives (COC) containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg) daily for 21 days starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2 will receive fluoxetine 20 mg daily in addition to an oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation.Group 3 will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation in addition to a daily oral placebo similar in size, color and structure to fluoxetine."},
{"id":"NCT02508103","registry":"ClinicalTrials.gov","slug":"emotional-processing-and-oxytocin-mechanisms-in-premenstrual-nct02508103","match":"direct","title":"Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study","official_title":"Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study","acronym":null,"status":"COMPLETED","phases":["PHASE2","PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["Premenstrual Dysphoric Disorder","Premenstrual Syndrome","PMS","PMDD"],"interventions":[{"type":"DRUG","name":"Oxytocin"},{"type":"DRUG","name":"Placebo"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":10,"enrollment_type":"ACTUAL","start_date":"2015-07","completion_date":"2016-07","first_posted":"2015-07-24","last_update":"2017-06-27","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT02508103?tab=results","url":"https://clinicaltrials.gov/study/NCT02508103","reference_pmids":[],"brief_summary":"This research study will look at brain and symptom differences among women with severe premenstrual mood symptoms. One goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in emotion regulation while viewing pictures during a neuroimaging (fMRI) session. The investigators will also look at whether oxytocin improves premenstrual mood symptoms."},
{"id":"NCT02488538","registry":"ClinicalTrials.gov","slug":"combined-oral-contraceptives-and-fluoxetine-versus-combined-nct02488538","match":"direct","title":"Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in Severe Premenstrual Syndrome","official_title":"The Synergistic Use of Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in the Management of Severe Premenstrual Syndrome: A Randomized Double Blind Placebo Controlled Trial","acronym":null,"status":"UNKNOWN","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Combined oral contraceptives"},{"type":"DRUG","name":"Fluoxetine"},{"type":"DRUG","name":"Combined oral contraceptives placebo"},{"type":"DRUG","name":"Fluoxetine placebo"},{"type":"PROCEDURE","name":"Daily record of severity of problems"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":300,"enrollment_type":"ESTIMATED","start_date":"2015-07","completion_date":"2017-07","first_posted":"2015-07-02","last_update":"2017-01-23","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02488538","reference_pmids":["15256354","16172836","9582073"],"brief_summary":"Three hundred women with severe premenstrual syndrome will be divided into 3 groups using computer generated random numbers. Group 1 will receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® ScheringAG, Egypt) daily for 21 days starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2 will receive COC containing drospirenone daily for 21 days starting from the 3rd day of menstruation in addition to a daily oral placebo similar in size, color and structure to fluoxetine . Group 3 will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation in addition to a daily oral placebo similar in size, color and structure to fluoxetine."},
{"id":"NCT02448836","registry":"ClinicalTrials.gov","slug":"deep-transcranial-magnetic-stimulation-dtms-for-the-nct02448836","match":"direct","title":"Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)","official_title":"Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"DEVICE","name":"dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil"},{"type":"DEVICE","name":"Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil"}],"sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_class":"OTHER_GOV","collaborators":[],"countries":[],"enrollment":30,"enrollment_type":"ESTIMATED","start_date":"2015-06","completion_date":"2016-12","first_posted":"2015-05-20","last_update":"2015-05-20","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02448836","reference_pmids":["42338742"],"brief_summary":"Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are limited, with 40% non-responders. Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is based on modulating neural activity by inducing an electric field in the brain. To date, dTMS was found to be an effective treatment for depression, which is highly comorbid with PMDD. The investigators propose to study the effect of dTMS on PMDD patients in a prospective treatment study."},
{"id":"NCT02504515","registry":"ClinicalTrials.gov","slug":"effect-of-homeopathy-acupuncture-or-anthroposophic-medicine-nct02504515","match":"direct","title":"Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life","official_title":"Evaluating Treatment With Homeopathy, Acupuncture, and Anthroposophic Medicine in Improving the Quality of Life for Women Treated at the Public Unified Healthcare System","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"HEALTH_SERVICES_RESEARCH","conditions":["Anxiety","Depression","Premenstrual Tension","Hot Flashes","Muscular Diseases"],"keywords":[],"interventions":[{"type":"OTHER","name":"World Health Organization Quality of Life Bref Questionnaire"}],"sponsor":"Federal University of Minas Gerais","sponsor_class":"OTHER","collaborators":["Conselho Nacional de Desenvolvimento Científico e Tecnológico"],"countries":["Brazil"],"enrollment":906,"enrollment_type":"ESTIMATED","start_date":"2015-04","completion_date":"2017-12","first_posted":"2015-07-22","last_update":"2017-05-03","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02504515","reference_pmids":[],"brief_summary":"Patients will be randomly assigned to two separate groups. Both patient groups will be evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before the study begins and at intervals of six months during a period of one year for a total of three evaluations. Group one will be made up of patients who will begin homeopathy or acupuncture or anthroposophic medicine treatment and patients from group two will start homeopathy or acupuncture or anthroposophic medicine six months after the beginning of the study. Each one of these three research branches will be done independently (Homeopathy versus control; Acupuncture versus control; Anthroposophic Medicine versus control). Conventional medical treatment will be available for all patients in both groups. A data sheet will be filled out on each patient with data as to age, education level, marital status and the patient's own perception of their health status. During the interviews the interviewer will have no influence whatsoever over the respondents' answers. Integrative/complementary or traditional medicine doctors do not participate in the research and will not be informed about which patients are participating in this project, and as such the research will be blinded for these doctors. Minitab software, version 16, was used for sample calculation through the module Power and Sample Size. Sample calculation option for paired t-tests before and after intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy branch (225 patients in the homeopathy group and 225 patients in the control group), 228 patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in the control group), and 228 patients for anthroposophic medicine branch (114 patients in the anthroposophic medicine group and 114 patients in the control group)."},
{"id":"NCT02427334","registry":"ClinicalTrials.gov","slug":"dienogest-versus-luteal-phase-fluoxetine-in-the-management-nct02427334","match":"direct","title":"Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome","official_title":"Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome: A Randomized Double Blind Placebo Controlled Trial","acronym":null,"status":"UNKNOWN","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dienogest"},{"type":"DRUG","name":"Fluoxetine"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":210,"enrollment_type":"ESTIMATED","start_date":"2015-04","completion_date":"2021-12","first_posted":"2015-04-28","last_update":"2020-12-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02427334","reference_pmids":["15256354","16172836","9582073"],"brief_summary":"Two hundreds and ten women with premenstrual syndrome will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive oral dienogest (visanne® Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation, Group 2 will receive fluoxetine (Prozac® Lilly, UK) 20mg and group 3 will receive an oral placebo foe 14 days starting from the 15th day of menstruation."},
{"id":"NCT02402049","registry":"ClinicalTrials.gov","slug":"homeopathic-treatment-of-premenstrual-syndrome-nct02402049","match":"direct","title":"Homeopathic Treatment of Premenstrual Syndrome","official_title":"Is Homeopathic Treatment a Placebo Treatment? - Homeopathic Treatment of Premenstrual Syndrome- A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial","acronym":null,"status":"UNKNOWN","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome-PMS"],"keywords":[],"interventions":[{"type":"DRUG","name":"Natrum muriaticum 30C"},{"type":"DRUG","name":"Lachesis 30C"},{"type":"DRUG","name":"Sepia 30C"},{"type":"DRUG","name":"Nux vomica 30C"},{"type":"DRUG","name":"Pulsatilla 30C"},{"type":"DRUG","name":"Folliculinum 30C"},{"type":"DRUG","name":"Placebo Natrum muriaticum"},{"type":"DRUG","name":"Placebo Lachesis"},{"type":"DRUG","name":"Placebo Sepia"},{"type":"DRUG","name":"Placebo Nux vomica"},{"type":"DRUG","name":"Placebo pulsatilla"},{"type":"DRUG","name":"Placebo Folliculinum"}],"sponsor":"Shaare Zedek Medical Center","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":180,"enrollment_type":"ESTIMATED","start_date":"2015-03","completion_date":"2016-03","first_posted":"2015-03-30","last_update":"2015-03-30","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02402049","reference_pmids":[],"brief_summary":"The proposed study will focus on premenstrual syndrome (PMS) symptom alleviation for women diagnosed as suffering from the syndrome with the DRSP questionnaire. The women will be treated with Homeopatic remedies. The improvement of PMS symptoms will be evaluated using the Daily Record of Severity of Problems questionnaire (DRSP). The questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment."},
{"id":"NCT02362191","registry":"ClinicalTrials.gov","slug":"targeting-inter-hemispheric-alpha-coherence-with-tacs-to-nct02362191","match":"direct","title":"Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD","official_title":"Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD","acronym":null,"status":"TERMINATED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Alternating Current Stimulator"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":["Foundation of Hope, North Carolina"],"countries":[],"enrollment":5,"enrollment_type":"ACTUAL","start_date":"2015-03","completion_date":"2020-03","first_posted":"2015-02-12","last_update":"2020-10-09","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT02362191?tab=results","url":"https://clinicaltrials.gov/study/NCT02362191","reference_pmids":[],"brief_summary":"Purpose: Using transcranial alternating current stimulation (tACS), we will study whether tACS induces changes in prefrontal alpha oscillatory frequencies in women with premenstrual dysphoric disorder (PMDD) and whether tACS effects on alpha oscillations varies by menstrual cycle phase. An exploratory objective is to assess whether there are any changes in symptom severity during the menstrual cycle phase in which tACS is delivered relative to their baseline symptom levels (determined in a diagnostic feeder study, see below). Participants: Women between ages 18-52 with a diagnosis of PMDD confirmed by participation in a PMDD diagnostic study (IRB# 05-3000). Procedures (methods): After a re-screening and consent appointment, eligible participants will alert the study staff when they begin menstruating. Participants will have their first session in either the follicular phase or luteal phase (determined by ovulation testing) of their menstrual cycle and the second session in the other cycle phase. The order of phase at first testing will be counterbalanced across participants. Each session will consist of 40 minutes of tACS with by an EEG recording before and after stimulation. Patients' symptoms will be assessed at the end of each session and with the daily mood ratings collected throughout the menstrual cycle that coincides with tACS sessions (approximately 26 - 32 days)."},
{"id":"NCT02809066","registry":"ClinicalTrials.gov","slug":"dietary-calcium-intake-in-premenstrual-syndrome-nct02809066","match":"direct","title":"Dietary Calcium Intake in Premenstrual Syndrome","official_title":"Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["premenstrual syndrome","calcium","quality of life"],"interventions":[{"type":"OTHER","name":"Sufficient dietary calcium intake in premenstrual syndrome"}],"sponsor":"Eastern Mediterranean University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":31,"enrollment_type":"ACTUAL","start_date":"2015-01","completion_date":"2016-01","first_posted":"2016-06-22","last_update":"2016-06-22","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02809066","reference_pmids":[],"brief_summary":"This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake."},
{"id":"NCT02481973","registry":"ClinicalTrials.gov","slug":"the-effect-of-individualised-homoeopathic-treatment-using-nct02481973","match":"direct","title":"The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome","official_title":"The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["PMS","Homoeopathy","Grant Bentley Method"],"interventions":[{"type":"OTHER","name":"Individualised Homoeopathic Remedy"}],"sponsor":"University of Johannesburg","sponsor_class":"OTHER","collaborators":[],"countries":["South Africa"],"enrollment":10,"enrollment_type":"ACTUAL","start_date":"2014-09","completion_date":"2015-10","first_posted":"2015-06-25","last_update":"2016-05-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02481973","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is related to the changes in the levels of hormones predominately progesterone, oestrogen and prolactin, during the luteal phase of the menstrual cycle. Both physical and psychological symptoms may occur from at least day 14 of the menstruation cycle and cease by day 4 of menstruation. The symptoms may interfere with a female's daily activities and have a negative impact well-being. There are a number of conventional pharmacological drugs which are used in the treatment or alleviation of the symptoms of PMS, however the drugs may have side effects and may negatively interact with other medications. Research has shown that homoeopathy is beneficial in relieving or decreasing the severity of PMS, however finding the individualised homoeopathic remedy can be difficult. Grant Bentley developed a system that helps find the most suitable remedy for each individual case. The Grant Bentley Method (GBM) uses homoeopathic case taking, photographs of the facial features and repertorisation to determine the dominant miasmatic group of the patient. This aids in the selection of specific homoeopathic remedy. There has been no research to show the effect of the GBM on PMS. This study aims to determine the effect of individualised homoeopathic treatment using the GBM, on females with PMS by using case studies and a daily self-grading PMS chart."},
{"id":"NCT02467088","registry":"ClinicalTrials.gov","slug":"an-observational-study-on-the-efficacy-of-individualised-nct02467088","match":"direct","title":"An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome","official_title":"An Observational Study on the Efficacy of Individualised Homoeopathic Treatment on Premenstrual Syndrome in Indian Females","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["PMS","Individualised homoeopathic treatment","Indian females"],"interventions":[{"type":"OTHER","name":"Individualised Homeopathic Remedy"}],"sponsor":"University of Johannesburg","sponsor_class":"OTHER","collaborators":[],"countries":["South Africa"],"enrollment":10,"enrollment_type":"ACTUAL","start_date":"2014-08","completion_date":"2015-08","first_posted":"2015-06-09","last_update":"2016-05-19","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02467088","reference_pmids":[],"brief_summary":"Premenstrual Syndrome (PMS) is a group of physical, mental and behavioural symptoms that occur cyclically through the luteal phase of the menstrual cycle and resolve within three days of the onset of menstruation. Many women are affected by the physical and psychological symptoms of PMS. The symptoms of PMS can change behaviour and wellbeing of women which has an impact on families, social life and work. Research has shown that women with PMS reported additional days missed at work compared to women that do not suffer with PMS. A study done by Brohi et al. (2011) showed that PMS is a common problem that occurs in 81.25% of women and has an adverse impact on a woman's quality of life. Conventional treatment is limited, not always effective and is associated with many side effects. Research using individualised homeopathic treatment, known as the homeopathic similimum, in PMS has shown to be well tolerated as well as have a positive impact on the symptoms of PMS although further research is warranted in this regard. There have not been any studies done on homeopathic treatment in Indian females in South Africa. The aim of this study is to determine the effect of individualised homeopathic treatment on females of Indian origin who are suffering with symptoms of PMS, using observational studies."},
{"id":"NCT02089620","registry":"ClinicalTrials.gov","slug":"comparison-between-oral-contraceptive-pills-and-calcium-nct02089620","match":"direct","title":"Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome","official_title":"Calcium Supplements Versus Oral Contraceptive Pills Containing Drospirenone in Treating Mild to Moderate Premenstrual Syndrome: A Double Blind Randomized Placebo Controlled Trial","acronym":"PMS","status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","Oral contraceptive pills","Calcium Supplements"],"interventions":[{"type":"DRUG","name":"Yasmin"},{"type":"DIETARY_SUPPLEMENT","name":"Calver"},{"type":"DRUG","name":"Placebo 1"},{"type":"DRUG","name":"Placebo 2"}],"sponsor":"Beni-Suef University","sponsor_class":"OTHER","collaborators":[],"countries":["Egypt"],"enrollment":210,"enrollment_type":"ACTUAL","start_date":"2014-05","completion_date":"2015-06","first_posted":"2014-03-18","last_update":"2015-08-11","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT02089620","reference_pmids":["11588078","16172836","26808666"],"brief_summary":"Premenstrual syndrome represents a group of problems affecting most of women in reproductive age. These problems include emotional and physical symptoms. In this study the efficacy of oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed ."},
{"id":"NCT06191536","registry":"ClinicalTrials.gov","slug":"the-effect-of-pve-applied-in-addition-to-pilates-on-nct06191536","match":"direct","title":"The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With PMS","official_title":"The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Pelvic Floor Disorders","Quality of Life"],"keywords":["Premenstrual Syndrome","Pelvic Floor Exercises","Pilates","Quality of Life","Pain"],"interventions":[{"type":"OTHER","name":"Pilates"},{"type":"OTHER","name":"Pelvic floor exercises"}],"sponsor":"Uskudar University","sponsor_class":"OTHER","collaborators":[],"countries":["Turkey (Türkiye)"],"enrollment":30,"enrollment_type":"ACTUAL","start_date":"2013-12-01","completion_date":"2024-07-20","first_posted":"2024-01-05","last_update":"2024-09-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06191536","reference_pmids":["20094704","22033000","35730511","36829334"],"brief_summary":"Premenstrual syndrome (PMS) is a condition that occurs with physical and psychological symptoms in the late luteal phase of the menstrual cycle in women and affects the physical and mental well-being of the individual. Physiological symptoms; edema, headache, fatigue, weight gain and breast swelling and tenderness, and psychological symptoms; It can be seen as tension, anger, depressed mood or stress. Although it usually ends with the onset of menstruation, its repetition with each menstrual cycle affects the individual's pain coping strategies, sleep and quality of life. Different methods such as pharmacological agents, physiotherapy applications, nutrition and lifestyle adjustments, breathing exercises, stress management, meditation and cognitive behavioral therapy are used to cope with PMS, which appears with symptoms of different severities from individual to individual."},
{"id":"NCT01945372","registry":"ClinicalTrials.gov","slug":"neurofeedback-treatment-of-affective-instability-in-nct01945372","match":"direct","title":"Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)","official_title":"Self-modulation of Prefrontal Alpha Asymmetry:Novel Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD)","acronym":null,"status":"UNKNOWN","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Depression","Premenstrual Dysphoric Disorder (PMDD)"],"keywords":[],"interventions":[{"type":"OTHER","name":"EEG NeuroFeedback"}],"sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_class":"OTHER_GOV","collaborators":[],"countries":["Israel"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2013-10","completion_date":"2019-08","first_posted":"2013-09-18","last_update":"2018-03-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01945372","reference_pmids":[],"brief_summary":"Premenstrual Dysphoric Disorder (PMDD) is characterized by affective instability and irritability, diagnosed in 5% of reproductive-age women. Although causing severe insult to patients' functioning and quality of life, \\~40% do not respond to conventional treatment options. In this study, the investigators aim to examine a novel therapeutic approach for the treatment of affective instability in PMDD: brain-guided training (i.e.NeuroFeedBack, NF) probed by prefrontal EEG alpha asymmetry. PMDD patients will be randomly assigned to either a real or sham EEG-NF protocol, and undergo simultaneous fMRI-EEG scans before and after training period. Comprehensive psychological assessment will be performed for outcome measure. The investigators hypothesize that EEG-NF treatment will enhance affective stability, thus improving patients' daily lives."},
{"id":"NCT01995916","registry":"ClinicalTrials.gov","slug":"wellness-intervention-for-menstrual-mood-disorders-nct01995916","match":"related","title":"Wellness Intervention for Menstrual Mood Disorders","official_title":"Intervention for Menstrual Mood Disorders & Early Life Abuse: BioPsych Mechanisms","acronym":"WIMM","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Menstrual Mood Disorders"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Mindfulness Intervention"},{"type":"BEHAVIORAL","name":"Social Support Group"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":300,"enrollment_type":"ACTUAL","start_date":"2013-08-28","completion_date":"2018-05-31","first_posted":"2013-11-27","last_update":"2018-11-20","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01995916","reference_pmids":["33259351"],"brief_summary":"This study has been funded by National Institute of Mental Health (NIMH) to compare two behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric disorder (PMDD). Both of these interventions will be run in a group format, meaning that you will be part of a group of other women who have a menstrual mood disorder. Both of these interventions will be run by experienced mental health professionals and both interventions have been shown to be effective in reducing mood symptoms, increasing a sense of well-being, and helping individuals cope with stress. While it is expected that both interventions to be associated with some benefit, this study is designed to see which is better for women with a menstrual mood disorder."},
{"id":"NCT01961479","registry":"ClinicalTrials.gov","slug":"treatment-of-premenstrual-syndrome-internet-based-self-help-nct01961479","match":"direct","title":"Treatment of Premenstrual Syndrome - Internet-based Self-help","official_title":"Development and Evaluation of an Internet-based Cognitive Behaviour Therapy for Women With Premenstrual Syndrome (PMS)","acronym":"praemensis","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome (PMS)"],"keywords":["Premenstrual syndrome (PMS)","Premenstrual Dysphoric Disorder (PMDD)","Internet-based Therapy","Cognitive Behavioural Therapy (CBT)"],"interventions":[{"type":"BEHAVIORAL","name":"Internet-based CBT for patients with PMS"},{"type":"OTHER","name":"Waiting list"}],"sponsor":"Philipps University Marburg","sponsor_class":"OTHER","collaborators":["Linkoeping University"],"countries":["Germany"],"enrollment":174,"enrollment_type":"ACTUAL","start_date":"2013-07","completion_date":"2018-04","first_posted":"2013-10-11","last_update":"2018-04-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01961479","reference_pmids":["11030291","12217456","12892987","18415443","18852497","19018554","22426857","25467540","9350019"],"brief_summary":"The purpose of this study is to determine whether an internet-based CBT (iCBT) is effective in reducing the impairment caused by premenstrual symptoms."},
{"id":"NCT01799733","registry":"ClinicalTrials.gov","slug":"alternative-treatments-for-premenstrual-dysphoric-disorder-nct01799733","match":"direct","title":"Alternative Treatments for Premenstrual Dysphoric Disorder","official_title":"Alternative Treatments for Premenstrual Dysphoric Disorder","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["Premenstrual Dysphoric Disorder","Women","Depression","Light therapy","Wake therapy","Phase","Chronobiology"],"interventions":[{"type":"OTHER","name":"LWT+AM BWL"},{"type":"OTHER","name":"EWT+PM BWL"}],"sponsor":"University of California, San Diego","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":43,"enrollment_type":"ACTUAL","start_date":"2013-06-18","completion_date":"2018-07-03","first_posted":"2013-02-27","last_update":"2022-02-04","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01799733","reference_pmids":["36520251"],"brief_summary":"The primary aim of this study is to examine the effects of co-administered wake therapy followed by light treatment on mood, and secondarily on circadian rhythms, to test the hypothesis that critically-timed chronotherapy improves mood by correcting phase disturbances in melatonin and sleep in women with Premenstrual Dysphoric Disorder."},
{"id":"NCT01870687","registry":"ClinicalTrials.gov","slug":"efficacy-and-safety-of-20-mg-2-tablets-of-10mg-vac-bno-1095-nct01870687","match":"direct","title":"Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS","official_title":"Prospective, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Randomized Clinical Trial to Proof Efficacy and Safety of 20 mg (2 Tablets of 10 mg) VAC BNO 1095 FCT in Patients Suffering From Cyclic Mastodynia and PMS","acronym":null,"status":"TERMINATED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Mastodynia"],"keywords":["vitex agnus castus","clinical trial","cyclic mastodynia","PMS","prospective"],"interventions":[{"type":"DRUG","name":"20mg VAC BNO 1095 FCT"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Bionorica SE","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Germany"],"enrollment":96,"enrollment_type":"ACTUAL","start_date":"2013-06","completion_date":"2014-10","first_posted":"2013-06-06","last_update":"2016-09-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01870687","reference_pmids":[],"brief_summary":"The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre menstrual syndrome)."},
{"id":"NCT01875718","registry":"ClinicalTrials.gov","slug":"a-phase-i-ii-study-to-evaluate-uc1010-treatment-in-nct01875718","match":"direct","title":"A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)","official_title":"A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study","acronym":null,"status":"COMPLETED","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"UC1010"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Umecrine Mood AB","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Sweden"],"enrollment":146,"enrollment_type":"ESTIMATED","start_date":"2013-01","completion_date":"2014-06","first_posted":"2013-06-12","last_update":"2015-01-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01875718","reference_pmids":[],"brief_summary":"The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1. In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group."},
{"id":"NCT01912391","registry":"ClinicalTrials.gov","slug":"clinical-research-study-to-evaluate-selegiline-in-the-nct01912391","match":"direct","title":"Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder","official_title":"A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Borderline Personality Disorder"],"keywords":["Depression","Anxiety","Headaches","Migraines","Irritable Bowel Syndrome IBS","Neurodermatitis","Fibromyalgia","Premenstrual Syndrome PMS","Temporomandibular Joint Dysfunction TMJ"],"interventions":[{"type":"DRUG","name":"Selegiline"},{"type":"DRUG","name":"Placebo (for Selegiline)"}],"sponsor":"Mood and Anxiety Research, Inc","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":30,"enrollment_type":"ACTUAL","start_date":"2012-10","completion_date":"2015-03","first_posted":"2013-07-31","last_update":"2015-10-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01912391","reference_pmids":["36375174"],"brief_summary":"Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder."},
{"id":"NCT01365676","registry":"ClinicalTrials.gov","slug":"gamaline-hipericin-for-pms-treatment-and-vasomotor-symptoms-nct01365676","match":"direct","title":"GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms","official_title":"Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms","acronym":"657/10UFCSPA","status":"UNKNOWN","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Uterus; Hemorrhage, Preclimacteric or Premenopausal"],"keywords":["Edema","Depression","Hot Flashes","Anxiety","Irritability","PMS"],"interventions":[{"type":"DRUG","name":"GAMALINE® + HIPERICIN®"},{"type":"DRUG","name":"GAMALINE®"}],"sponsor":"Phytopharm Consulting Brazil","sponsor_class":"NETWORK","collaborators":["Herbarium Laboratorio Botanico Ltda","Federal University of Health Science of Porto Alegre"],"countries":["Brazil"],"enrollment":240,"enrollment_type":"ESTIMATED","start_date":"2012-03","completion_date":"2012-12","first_posted":"2011-06-03","last_update":"2011-12-06","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01365676","reference_pmids":[],"brief_summary":"2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as antidepressant will be prescribed together for treating women with Premenstrual Syndrome (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE® prescription alone."},
{"id":"NCT06584669","registry":"ClinicalTrials.gov","slug":"investigation-of-krill-oil-in-women-with-premenstrual-nct06584669","match":"direct","title":"Investigation of Krill Oil in Women with Premenstrual Syndrome","official_title":"Investigation of Krill Oil in Women with Premenstrual Syndrome: a Randomized, Placebo-controlled, Double-blind, Parallel Group Study with Different Dosages","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome"],"keywords":["inflammation","krill oil","omega-3 fatty acids","premenstrual syndrome"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Krill oil"},{"type":"OTHER","name":"Placebo"}],"sponsor":"Aker BioMarine Human Ingredients AS","sponsor_class":"INDUSTRY","collaborators":["BioTeSys GmbH"],"countries":["Germany"],"enrollment":179,"enrollment_type":"ACTUAL","start_date":"2012-02-23","completion_date":"2013-08-23","first_posted":"2024-09-05","last_update":"2024-09-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT06584669","reference_pmids":[],"brief_summary":"In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed."},
{"id":"NCT01445808","registry":"ClinicalTrials.gov","slug":"psychodynamic-motivation-and-training-program-nct01445808","match":"direct","title":"Psychodynamic Motivation and Training Program","official_title":"Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease","acronym":"PMT","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Coronary Heart Disease","Physical Activity"],"keywords":["psychodynamic psychotherapy","coronary heart disease","physical activity","secondary prevention"],"interventions":[{"type":"BEHAVIORAL","name":"Psychodynamic Motivation and Training Program (PMT)"},{"type":"BEHAVIORAL","name":"Advice in Exercise Training (+Ex)"},{"type":"OTHER","name":"Treatment as usual (TAU)"}],"sponsor":"Johannes Gutenberg University Mainz","sponsor_class":"OTHER","collaborators":[],"countries":["Germany"],"enrollment":90,"enrollment_type":"ACTUAL","start_date":"2011-10","completion_date":"2015-02","first_posted":"2011-10-04","last_update":"2016-02-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01445808","reference_pmids":["24066805"],"brief_summary":"The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual."},
{"id":"NCT01482338","registry":"ClinicalTrials.gov","slug":"premenstrual-symptoms-treatment-comparing-between-oral-nct01482338","match":"direct","title":"Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone","official_title":"A Comparative Efficacy of Low-dose Combine Oral Contraceptives Containing Desogestrel 150 mg and Drospirenone 3 mg on Premenstrual Symptoms","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["PMS","Low-dose combine contraceptives pills","COC"],"interventions":[{"type":"DRUG","name":"EE 20 microgram with desogestrel 150 mg"},{"type":"DRUG","name":"EE 20 microgram with drospirenone 3 mg"}],"sponsor":"Chulalongkorn University","sponsor_class":"OTHER","collaborators":[],"countries":["Thailand"],"enrollment":90,"enrollment_type":"ACTUAL","start_date":"2011-06","completion_date":"2012-03","first_posted":"2011-11-30","last_update":"2012-03-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01482338","reference_pmids":["1042815","10674591","10830769","11249391","15037415","15157791","15451331","16206030","16307962","16734317","19370644","5812581","8842582"],"brief_summary":"The purpose of this study is to determine whether low-dose combine oral contraceptives (COC) containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of Premenstrual symptoms."},
{"id":"NCT01309113","registry":"ClinicalTrials.gov","slug":"dose-dependent-effects-of-vac-bno-1095-on-cyclic-mastodynia-nct01309113","match":"direct","title":"Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome","official_title":"Double-blind Comparison of VAC BNO 1095 Film Coated Tablets With Placebo to Identify Dose Dependent Effects in Patients Suffering From Cyclic Mastodynia and Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Cyclic Mastodynia","Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"VAC BNO 1095 film coated tablets"}],"sponsor":"Bionorica SE","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Czechia"],"enrollment":191,"enrollment_type":"ACTUAL","start_date":"2011-03","completion_date":"2012-11","first_posted":"2011-03-04","last_update":"2013-07-09","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01309113","reference_pmids":[],"brief_summary":"Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol. Study objectives: Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome. To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia. Dose regimen: Group 1: VAC BNO 1095 1x10 mg: 1 tablet of verum in the morning, 1 placebo tablet in the evening Group 2: VAC BNO 1095 2x10 mg: 1 tablet of verum in the morning, 1 tablet of verum in the evening Group 3: Placebo: 1 tablet placebo in the morning, 1 tablet placebo in the evening The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively. Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the first run-in cycle. Subsequently the time between the first study visit and the onset of the first run-in cycle menses T shall be added to the overall study duration. In case that the next menstruation does not commence as expected, the patient should contact her investigator immediately in order to schedule a new appointment, approximately on the actual day 3 of the menses."},
{"id":"ISRCTN57661673","registry":"ISRCTN","slug":"evaluation-of-the-extended-regimen-versus-standard-regimen-isrctn57661673","match":"direct","title":"Evaluation of the extended regimen versus standard regimen of oral contraceptive in premenstrual and/or menstrual symptoms","official_title":"A randomised multicentre parallel-group, comparative, prospective, open label study to assess the effect of extended regimen versus standard regimen of the oral contraceptive 3 mg drospirenone/20 µg ethinyl estradiol in premenstrual and/or menstrual symptoms","acronym":null,"status":"NO_LONGER_RECRUITING","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual symptoms"],"keywords":["Urological and Genital Diseases","Premenstrual symptoms"],"interventions":[{"type":"Drug","name":null}],"sponsor":"LIBBS Farmaceutica Ltd (Brazil)","sponsor_class":null,"collaborators":[],"countries":["Brazil"],"enrollment":348,"enrollment_type":"ACTUAL","start_date":"2011-01-10","completion_date":"2012-02-28","first_posted":"2010-10-05","last_update":null,"has_results":true,"results_url":"https://pubmed.ncbi.nlm.nih.gov/32280282","url":"https://www.isrctn.com/ISRCTN57661673","reference_pmids":[],"brief_summary":null},
{"id":"NCT01782040","registry":"ClinicalTrials.gov","slug":"auriculotherapy-in-the-cares-to-the-premenstrual-syndrome-nct01782040","match":"direct","title":"Auriculotherapy in the Cares to the Premenstrual Syndrome","official_title":"Auriculotherapy in the Cares to the Premenstrual Syndrome: Randomized Clinical Trial","acronym":null,"status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","Physical distress","Behavioral changes"],"interventions":[{"type":"OTHER","name":"Auriculotherapy group"}],"sponsor":"University of Sao Paulo","sponsor_class":"OTHER","collaborators":["Sociedade Hospital Samaritano"],"countries":["Brazil"],"enrollment":40,"enrollment_type":"ACTUAL","start_date":"2011-01","completion_date":"2012-07","first_posted":"2013-02-01","last_update":"2013-02-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01782040","reference_pmids":[],"brief_summary":"Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a woman's menstrual cycle. These symptoms occurring only during the luteal phase of the menstrual cycle that are of sufficient severity to interfere with some aspects of life of these women, reflecting also in interpersonal relationships, workplace and in their productivity. For these reasons, this research was conducted with the nursing staff of the Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate some of the symptoms of PMS."},
{"id":"NCT04348201","registry":"ClinicalTrials.gov","slug":"foot-reflexology-on-premenstrual-syndrome-nct04348201","match":"direct","title":"Foot Reflexology on Premenstrual Syndrome","official_title":"Foot Reflexology Combined With Dietary Modification on Premenstrual Syndrome","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Reflexology","Dietary Modification"],"keywords":[],"interventions":[{"type":"OTHER","name":"foot reflexology"},{"type":"DIETARY_SUPPLEMENT","name":"dietary modification"}],"sponsor":"Cairo University","sponsor_class":"OTHER","collaborators":[],"countries":[],"enrollment":50,"enrollment_type":"ACTUAL","start_date":"2010-06-24","completion_date":"2020-01-30","first_posted":"2020-04-16","last_update":"2020-04-17","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT04348201","reference_pmids":[],"brief_summary":": Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies"},
{"id":"NCT01125774","registry":"ClinicalTrials.gov","slug":"telcagepant-for-prevention-of-menstrually-related-migraine-nct01125774","match":"direct","title":"Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)","official_title":"A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine","acronym":null,"status":"COMPLETED","phases":["PHASE2","PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Migraine"],"keywords":["Menstrually related migraine","migraine","Premenstrual migraine"],"interventions":[{"type":"DRUG","name":"Telcagepant"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Merck Sharp & Dohme LLC","sponsor_class":"INDUSTRY","collaborators":[],"countries":[],"enrollment":4548,"enrollment_type":"ACTUAL","start_date":"2010-06-01","completion_date":"2011-04-08","first_posted":"2010-05-18","last_update":"2018-10-23","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT01125774?tab=results","url":"https://clinicaltrials.gov/study/NCT01125774","reference_pmids":["25926620"],"brief_summary":"This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants."},
{"id":"NCT01073878","registry":"ClinicalTrials.gov","slug":"athena-pelvic-muscle-trainer-duets-trial-nct01073878","match":"direct","title":"Athena Pelvic Muscle Trainer - DUETS Trial","official_title":"Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction \"Athena D.U.E.T.S. Trial\"","acronym":"DUETS","status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"NA","primary_purpose":null,"conditions":["Urinary Incontinence"],"keywords":["Urinary Urge Incontinence","Urinary Stress Incontinence","Urinary Mixed Incontinence"],"interventions":[{"type":"DEVICE","name":"Athena Pelvic Muscle Trainer"}],"sponsor":"Athena Feminine Technologies, Inc.","sponsor_class":"INDUSTRY","collaborators":[],"countries":["United States","Virgin Islands"],"enrollment":462,"enrollment_type":"ACTUAL","start_date":"2010-02","completion_date":"2011-06","first_posted":"2010-02-23","last_update":"2011-07-14","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01073878","reference_pmids":[],"brief_summary":"The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic floor muscles by collecting data from the patient on the 1. Over Active Bladder Questionnaire 2. The 7-Day Urine Diary questionnaire This study will also look at whether or not there is an improvement in sexual health after using the device by collecting data frm the patient on the 3. Female Sexual Function Index questionnaire"},
{"id":"NCT01291056","registry":"ClinicalTrials.gov","slug":"differential-effects-of-clomiphene-citrate-in-women-nct01291056","match":"related","title":"Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation","official_title":"Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation: A Double-blind, Placebo-controlled, Crossover Study","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":null,"conditions":["Mood"],"keywords":["Clomiphene citrate","Mood symptoms","Infertility","Superovulation","Effects of clomiphene on mood"],"interventions":[{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"Clomiphene"}],"sponsor":"University of Utah","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":20,"enrollment_type":"ACTUAL","start_date":"2010-01","completion_date":"2011-05","first_posted":"2011-02-07","last_update":"2016-06-28","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT01291056?tab=results","url":"https://clinicaltrials.gov/study/NCT01291056","reference_pmids":[],"brief_summary":"Clomiphene citrate is commonly used for ovulation induction in women with anovulation, correction of luteal phase deficiency or for superovulation as empiric therapy for unexplained infertility. Superovulation using clomiphene, usually with intrauterine insemination, is usually regarded as first line therapy for unexplained infertility, infertility due to mild endometriosis, or infertility with mild or moderate compromise of the male factor. The side effect profile reported by some women using clomiphene citrate is similar to symptoms of premenstrual dysphoric disorder (PMDD), including tension, irritability, depressed mood, affective lability, lack of energy, difficulty concentrating, and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain. Few studies have been performed to examine the relationship between clomiphene citrate and mood symptoms; however, these studies have been limited by their small sample size, potential for recall bias and lack of randomization. Moreover, the experience of infertility is dysphoric in and of itself. Therefore, a rigorous evaluation of whether, when in the cycle, and how often clomiphene is associated with mood changes is needed. Such a study would add to the body of literature on this topic in three important ways: 1) use of prospective data collection to more accurately identify commonly reported symptoms, 2) characterize the timing of symptom occurrence relative to treatment cycle, and 3) provide information relevant to planning of future studies involving targeted treatment of clomiphene citrate induced symptoms. If clomiphene use is shown to affect mood, the results would point to an important avenue for psychopharmacologic insight into relationships between mood and sex steroids. OBJECTIVES: Specific Aim #1: To identify psychological and physical symptoms experienced by women taking clomiphene citrate for superovulation in a prospective, placebo controlled trial setting. Specific Aim #2: To determine whether measures of the emotional and physical state prior to the administration of clomiphene, predict the occurrence of mood changes during the five days of clomiphene administration and in the late follicular and luteal phases of the cycle in which clomiphene was administered."},
{"id":"NCT00998257","registry":"ClinicalTrials.gov","slug":"regulatory-post-marketing-surveillance-study-on-yaz-nct00998257","match":"direct","title":"Regulatory Post Marketing Surveillance Study on YAZ","official_title":"Regulatory Post Marketing Surveillance Study on YAZ","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Contraception","Premenstrual Syndrome","Acne"],"keywords":["Contraception","Premenstrual Dysphoric Disorder","PMDD","Acne"],"interventions":[{"type":"DRUG","name":"EE20/DRSP (YAZ, BAY86-5300)"}],"sponsor":"Bayer","sponsor_class":"INDUSTRY","collaborators":[],"countries":["South Korea"],"enrollment":770,"enrollment_type":"ACTUAL","start_date":"2009-07","completion_date":"2011-11","first_posted":"2009-10-20","last_update":"2015-01-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00998257","reference_pmids":[],"brief_summary":"The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice."},
{"id":"NCT00873262","registry":"ClinicalTrials.gov","slug":"evaluation-of-safety-efficacy-of-diagnostic-skin-test-panel-nct00873262","match":"direct","title":"Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)","official_title":"A Phase II Randomized, Two-arms, Single-blind, Cross Controlled Study for Evaluation the Safety and Efficacy of Diagnosis and Treatment of Premenstrual Syndrome by Detecting Skin Reactions Followed by Desensitization to Sex Hormones","acronym":null,"status":"UNKNOWN","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["PreMenstrual Syndrome","Hormones","Skin tests","Desensitization","Allergen Immunotherapy"],"interventions":[{"type":"DRUG","name":"Skin test panel and desensitization kit"},{"type":"DRUG","name":"Skin test panel and solvent"}],"sponsor":"EVE Medical Systems Ltd.","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Israel"],"enrollment":20,"enrollment_type":"ESTIMATED","start_date":"2009-04","completion_date":"2010-11","first_posted":"2009-04-01","last_update":"2010-06-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00873262","reference_pmids":[],"brief_summary":"The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms. The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the eligibility of the patients to enter a desensitization protocol. During the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. The end-point of the study is a statistically significant decrease, or elimination of PMS symptoms, compared to a solvent group."},
{"id":"NCT00866437","registry":"ClinicalTrials.gov","slug":"evaluation-of-efficacy-safety-of-eve-pms-skin-test-panel-nct00866437","match":"direct","title":"Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel","official_title":"Prospective, Controlled, Single-blinded, Longitudinal, Two-arms, Clinical Study Evaluation of Efficacy/Safety of EVE-PMS Skin-Test Panel -Detecting Sensitivity to Sex Hormones in Women With Premenstrual Syndrome","acronym":null,"status":"UNKNOWN","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"DIAGNOSTIC","conditions":["Premenstrual Syndrome"],"keywords":["PMS","Hormones","Skin tests","Allergen Immunotherapy"],"interventions":[{"type":"DRUG","name":"Skin test panel"},{"type":"DRUG","name":"Skin test panel"}],"sponsor":"EVE Medical Systems Ltd.","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Israel"],"enrollment":40,"enrollment_type":"ESTIMATED","start_date":"2009-04","completion_date":"2010-11","first_posted":"2009-03-20","last_update":"2010-06-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00866437","reference_pmids":[],"brief_summary":"The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS). The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients."},
{"id":"NCT00837395","registry":"ClinicalTrials.gov","slug":"inflammatory-mediators-and-microrna-analysis-in-premenstrual-nct00837395","match":"direct","title":"Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma","official_title":"Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma","acronym":null,"status":"TERMINATED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Asthma"],"keywords":["premenstrual increase in asthma symptoms"],"interventions":[],"sponsor":"Ohio State University","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":24,"enrollment_type":"ACTUAL","start_date":"2009-02","completion_date":"2019-12","first_posted":"2009-02-05","last_update":"2020-04-28","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00837395","reference_pmids":[],"brief_summary":"A small number of women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period. This study is being done to investigate the possible causes of this premenstrual increase in asthma symptoms and to help asthma care providers identify those patients who may suffer from this condition."},
{"id":"NCT00824187","registry":"ClinicalTrials.gov","slug":"yaz-premenstrual-dysphoric-disorder-pmdd-in-china-nct00824187","match":"direct","title":"YAZ Premenstrual Dysphoric Disorder (PMDD) in China","official_title":"A Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Monophasic Oral Contraceptive YAZ (20 µg Ethinylestradiol, 3 mg Drospirenone) in the Treatment of Chinese Patients With Premenstrual Dysphoric Disorder (PMDD)","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder ( PMDD)"],"keywords":["Premenstrual Dysphoric Disorder ( PMDD)","Oral contraceptive"],"interventions":[{"type":"DRUG","name":"EE20/DRSP(YAZ, BAY86-5300)"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Bayer","sponsor_class":"INDUSTRY","collaborators":[],"countries":["China"],"enrollment":187,"enrollment_type":"ACTUAL","start_date":"2009-01","completion_date":"2011-01","first_posted":"2009-01-16","last_update":"2014-04-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00824187","reference_pmids":[],"brief_summary":"The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD)."},
{"id":"NCT01385709","registry":"ClinicalTrials.gov","slug":"the-influence-of-the-menstrual-cycle-on-lithium-and-nct01385709","match":"direct","title":"The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels","official_title":"The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Bipolar Affective Disorders","Cyclothymic Disorder","Schizoaffective Disorder","Major Depressive Disorder","Dysthymic Disorder","Obsessive-Compulsive Disorder","Panic Disorder","Posttraumatic Stress Disorder","Premenstrual Dysphoric Disorder","Social Anxiety Disorder"],"keywords":["Lithium","Sertraline"],"interventions":[],"sponsor":"Weill Medical College of Cornell University","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":29,"enrollment_type":"ACTUAL","start_date":"2008-08","completion_date":"2013-08","first_posted":"2011-06-30","last_update":"2017-02-20","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT01385709","reference_pmids":[],"brief_summary":"The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease."},
{"id":"NCT00927095","registry":"ClinicalTrials.gov","slug":"continuous-oral-contraceptive-treatment-in-premenstrual-nct00927095","match":"direct","title":"Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)","official_title":"Continuous OC Treatment in PMDD: Steroid Hormone Mechanisms","acronym":"PMDD","status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["PMDD","Oral contraceptives","steroid hormones","neurosteroids"],"interventions":[{"type":"DRUG","name":"Continuous OC (EE/DROS)"},{"type":"DRUG","name":"Intermittent OC (EE/DROS)"},{"type":"DRUG","name":"placebo"}],"sponsor":"University of North Carolina, Chapel Hill","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":67,"enrollment_type":"ACTUAL","start_date":"2008-07","completion_date":"2014-07","first_posted":"2009-06-24","last_update":"2016-08-24","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00927095?tab=results","url":"https://clinicaltrials.gov/study/NCT00927095","reference_pmids":["28715852"],"brief_summary":"The purpose of this study is to compare a low dose oral contraceptive (OC) given continuously (every day for three months) with the same low dose oral contraceptive given in an interrupted regimen (one week of inactive placebo pills each month) and with continuous placebo (inactive placebo given every day for three months). The primary hypothesis is that continuous OC will be significantly more effective in reducing premenstrual symptoms compared with either the interrupted OC or continuous placebo."},
{"id":"NCT00612235","registry":"ClinicalTrials.gov","slug":"premenstrual-dysphoric-disorder-and-antiepileptic-drugs-nct00612235","match":"direct","title":"Premenstrual Dysphoric Disorder and Antiepileptic Drugs","official_title":"Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Epilepsy"],"keywords":["epilepsy","lamotrigine","levetiracetam","carbamazepine","phenytoin","lamictal","keppra","tegretol","carbatrol","dilantin"],"interventions":[{"type":"DRUG","name":"Lamotrigine"},{"type":"DRUG","name":"Levetiracetam"},{"type":"DRUG","name":"Carbamazepine"},{"type":"OTHER","name":"No Intervention"}],"sponsor":"Beth Israel Deaconess Medical Center","sponsor_class":"OTHER","collaborators":["Newton-Wellesley Hospital","Brigham and Women's Hospital"],"countries":["United States"],"enrollment":80,"enrollment_type":"ACTUAL","start_date":"2008-04","completion_date":"2010-06","first_posted":"2008-02-11","last_update":"2018-10-26","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00612235?tab=results","url":"https://clinicaltrials.gov/study/NCT00612235","reference_pmids":["21724471"],"brief_summary":"This study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy."},
{"id":"NCT00633360","registry":"ClinicalTrials.gov","slug":"the-oral-contraceptive-pill-for-premenstrual-worsening-of-nct00633360","match":"direct","title":"The Oral Contraceptive Pill for Premenstrual Worsening of Depression","official_title":"The Oral Contraceptive Pill for Premenstrual Worsening of Depression.","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Depression"],"keywords":["Women","PMS","Depression"],"interventions":[{"type":"DRUG","name":"Drospirenone and ethinyl estradiol"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Massachusetts General Hospital","sponsor_class":"OTHER","collaborators":["Bayer"],"countries":["United States"],"enrollment":32,"enrollment_type":"ACTUAL","start_date":"2008-02","completion_date":"2011-05","first_posted":"2008-03-12","last_update":"2017-03-20","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00633360?tab=results","url":"https://clinicaltrials.gov/study/NCT00633360","reference_pmids":[],"brief_summary":"To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression."},
{"id":"NCT00523705","registry":"ClinicalTrials.gov","slug":"escitalopram-for-premenstrual-syndrome-pms-in-teens-a-pilot-nct00523705","match":"direct","title":"Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study","official_title":"Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study","acronym":null,"status":"TERMINATED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["PMS"],"keywords":["premenstrual syndrome","PMS","PMDD","treatment","SSRI"],"interventions":[{"type":"DRUG","name":"escitalopram"},{"type":"OTHER","name":"placebo"}],"sponsor":"University of Pennsylvania","sponsor_class":"OTHER","collaborators":["Forest Laboratories"],"countries":["United States"],"enrollment":11,"enrollment_type":"ACTUAL","start_date":"2008-02","completion_date":"2009-10","first_posted":"2007-08-31","last_update":"2014-06-06","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00523705?tab=results","url":"https://clinicaltrials.gov/study/NCT00523705","reference_pmids":["17174829"],"brief_summary":"The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years."},
{"id":"NCT00536198","registry":"ClinicalTrials.gov","slug":"evaluating-the-effectiveness-of-sertraline-in-treating-women-nct00536198","match":"direct","title":"Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder","official_title":"Symptom Onset Antidepressant Treatment for PMDD","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["Premenstrual Syndrome"],"interventions":[{"type":"DRUG","name":"Sertraline"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Yale University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":252,"enrollment_type":"ACTUAL","start_date":"2007-11-06","completion_date":"2012-02","first_posted":"2007-09-27","last_update":"2017-04-14","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00536198?tab=results","url":"https://clinicaltrials.gov/study/NCT00536198","reference_pmids":["17454164","17470584","17937566","18328013","18395582","22393222","26351969","37212651"],"brief_summary":"This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder."},
{"id":"NCT00534846","registry":"ClinicalTrials.gov","slug":"the-effect-of-toremifene-treatment-to-the-magnetic-resonance-nct00534846","match":"direct","title":"The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia","official_title":"The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Breast Pain"],"keywords":["premenstrual syndrome","mastalgia","toremifene","selective estrogen receptor modulators"],"interventions":[{"type":"DRUG","name":"toremifene"},{"type":"DRUG","name":"placebo"}],"sponsor":"Satakunta Central Hospital","sponsor_class":"OTHER","collaborators":["Tampere University"],"countries":["Finland"],"enrollment":10,"enrollment_type":"ACTUAL","start_date":"2007-04","completion_date":"2009-02","first_posted":"2007-09-26","last_update":"2009-05-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00534846","reference_pmids":["16709215"],"brief_summary":"The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia."},
{"id":"NCT00472615","registry":"ClinicalTrials.gov","slug":"menstrual-effects-on-mood-symptoms-in-bipolar-disorder-nct00472615","match":"related","title":"Menstrual Effects On Mood Symptoms in Bipolar Disorder","official_title":"Menstrual Effects On Mood Symptoms in Bipolar Disorder","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Bipolar Disorder"],"keywords":["Bipolar Disorder","Menstrual Cycle","Depression","Mania or Hypomania","Predictor"],"interventions":[],"sponsor":"University of Pittsburgh","sponsor_class":"OTHER","collaborators":[],"countries":["United States"],"enrollment":45,"enrollment_type":"ESTIMATED","start_date":"2006-08","completion_date":"2008-06","first_posted":"2007-05-14","last_update":"2009-02-26","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00472615","reference_pmids":[],"brief_summary":"Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking. Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment."},
{"id":"NCT00195559","registry":"ClinicalTrials.gov","slug":"study-evaluating-combination-of-levonorgestrel-and-ethinyl-nct00195559","match":"direct","title":"Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder","official_title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome","Menstruation Disturbances"],"keywords":["Premenstrual Syndrome (PMS)","Hormone Therapy"],"interventions":[{"type":"DRUG","name":"Levonorgestrel/Ethinyl Estradiol"}],"sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Argentina","Brazil","Chile","Denmark","Finland","Germany","Mexico","Netherlands","Poland","Romania","Sweden","United Kingdom"],"enrollment":526,"enrollment_type":"ESTIMATED","start_date":"2005-09","completion_date":"2007-12","first_posted":"2005-09-19","last_update":"2007-12-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00195559","reference_pmids":[],"brief_summary":"The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder."},
{"id":"NCT00174161","registry":"ClinicalTrials.gov","slug":"the-symptom-experience-of-women-with-perimenstrual-syndrome-nct00174161","match":"direct","title":"The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.","official_title":null,"acronym":null,"status":"UNKNOWN","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome,Health Related Quality of Life"],"interventions":[{"type":"BEHAVIORAL","name":"self-care, health behavior"}],"sponsor":"National Taiwan University Hospital","sponsor_class":"OTHER","collaborators":["National Science and Technology Council, Taiwan"],"countries":["Taiwan"],"enrollment":1000,"enrollment_type":null,"start_date":"2005-08","completion_date":"2005-12","first_posted":"2005-09-15","last_update":"2005-09-15","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00174161","reference_pmids":[],"brief_summary":"The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains."},
{"id":"NCT00128934","registry":"ClinicalTrials.gov","slug":"study-evaluating-combination-of-levonorgestrel-lng-and-nct00128934","match":"direct","title":"Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder","official_title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Menstruation Disturbances","Premenstrual Syndrome"],"keywords":["Premenstrual Syndrome (PMS)","Hormone Therapy"],"interventions":[{"type":"DRUG","name":"levonorgestrel/ethinyl estradiol"}],"sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_class":"INDUSTRY","collaborators":[],"countries":["Canada","United States"],"enrollment":744,"enrollment_type":"ESTIMATED","start_date":"2005-08","completion_date":"2007-12","first_posted":"2005-08-10","last_update":"2007-12-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00128934","reference_pmids":["22067793"],"brief_summary":"The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS)."},
{"id":"NCT00161681","registry":"ClinicalTrials.gov","slug":"study-evaluating-levonorgestrel-ethinyl-estradiol-lng-ee-in-nct00161681","match":"direct","title":"Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS","official_title":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms","acronym":null,"status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"PREVENTION","conditions":["Premenstrual Syndrome"],"keywords":["Levonorgestrel","ethinyl estradiol","premenstrual syndrome","menstrual cycle related symptoms"],"interventions":[{"type":"DRUG","name":"Levonorgestrel/Ethinyl Estradiol"}],"sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_class":"INDUSTRY","collaborators":[],"countries":["United States"],"enrollment":200,"enrollment_type":null,"start_date":"2005-07","completion_date":"2006-08","first_posted":"2005-09-12","last_update":"2013-02-08","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00161681","reference_pmids":[],"brief_summary":"The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms."},
{"id":"ISRCTN31487459","registry":"ISRCTN","slug":"the-efficacy-of-treatment-with-st-johns-wort-for-isrctn31487459","match":"direct","title":"The efficacy of treatment with St John’s Wort for premenstrual syndrome (PMS)","official_title":"A randomised, double-blind, placebo-controlled trial to test the efficacy of Hypericum perforatum (St John’s Wort) as a treatment for premenstrual syndrome (PMS)","acronym":null,"status":"NO_LONGER_RECRUITING","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Pre-menstrual syndrome (PMS)"],"keywords":["Urological and Genital Diseases","Pain and other conditions associated with female genital organs and menstrual cycle"],"interventions":[{"type":"Drug","name":null}],"sponsor":"University of Leeds (UK)","sponsor_class":null,"collaborators":[],"countries":["England","United Kingdom"],"enrollment":41,"enrollment_type":"ESTIMATED","start_date":"2005-06-01","completion_date":"2007-01-01","first_posted":"2009-04-03","last_update":null,"has_results":true,"results_url":"http://www.ncbi.nlm.nih.gov/pubmed/20155996","url":"https://www.isrctn.com/ISRCTN31487459","reference_pmids":[],"brief_summary":null},
{"id":"NCT00672607","registry":"ClinicalTrials.gov","slug":"a-clinical-trial-to-evaluate-the-efficacy-and-safety-of-nct00672607","match":"direct","title":"a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)","official_title":null,"acronym":"ACT-RCT-C 01","status":"COMPLETED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["premenstual syndrome, PMS, clinical trial"],"interventions":[{"type":"DRUG","name":"extracts of Vitex agnus castus tablets"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Schwabe-Wenex International Ltd","sponsor_class":"INDUSTRY","collaborators":[],"countries":["China"],"enrollment":217,"enrollment_type":"ACTUAL","start_date":"2005-02","completion_date":"2007-01","first_posted":"2008-05-06","last_update":"2009-10-01","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00672607","reference_pmids":[],"brief_summary":"To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on efficacy or not."},
{"id":"NCT00611923","registry":"ClinicalTrials.gov","slug":"effectiveness-of-flutamide-in-treating-women-with-nct00611923","match":"direct","title":"Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder","official_title":"Androgen Hormones in PMDD","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Dysphoric Disorder","PMDD","PMS"],"interventions":[{"type":"DRUG","name":"Flutamide"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Weill Medical College of Cornell University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":[],"enrollment":115,"enrollment_type":"ACTUAL","start_date":"2005-02","completion_date":"2011-12","first_posted":"2008-02-11","last_update":"2020-01-07","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00611923?tab=results","url":"https://clinicaltrials.gov/study/NCT00611923","reference_pmids":[],"brief_summary":"This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder."},
{"id":"NCT00100360","registry":"ClinicalTrials.gov","slug":"hormonal-causes-of-menstrual-related-mood-disorders-nct00100360","match":"direct","title":"Hormonal Causes of Menstrual-Related Mood Disorders","official_title":"5HT1A and SERT Imaging During Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Mood Disorders","Depression"],"keywords":["Gonadal Steroids","GnRH Agonist","Depression","Menstrual Cycle","Menstrually Related Mood Disorder","MRMD","Healthy Volunteer","HV"],"interventions":[],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":22,"enrollment_type":"ACTUAL","start_date":"2004-12-22","completion_date":"2016-12-15","first_posted":"2004-12-30","last_update":"2018-07-05","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00100360","reference_pmids":["10368772","10579806","12062903"],"brief_summary":"This study will explore possible hormonal causes of menstrual-related mood disorders (MRMD) by stopping the menstrual cycle with a drug called Lupron and then giving in sequence two menstrual cycle hormones, progesterone and estrogen. The study will first evaluate Lupron's effectiveness in treating MRMD and will then examine the effects of giving estrogen and progesterone on mood and behavior. In addition, positron emission tomography (PET) and magnetic resonance imaging (MRI) will be used to study serotonin receptors and transporters - molecules in the brain that are thought to play a major role in mood changes related to the menstrual cycle. Menstruating women between 18 and 50 years of age who are in good health, not pregnant, and not taking medications may be eligible for this study. Women with MRMD must have had at least moderately severe MRMD or behavioral disturbances for at least 6 months within 2 years of entering the study. Healthy controls must have no history of MRMD or behavioral disturbances. Candidates undergo physical and neurological examinations, chest x-ray, electrocardiogram, and blood and urine tests. Results of a recent Pap smear (no longer than 12 months before beginning the study) must be available. Participants undergo the following tests and procedures: * Drug treatment: Lupron is injected into a muscle once a month for 5 months. After the second month, participants receive estrogen or progesterone, or both, daily. Estrogen is delivered through a skin patch (20 micrograms per day) and the progesterone is taken as a rectal or vaginal suppository twice a day for the remaining 12 weeks of the study. Every day, all participants wear a skin patch and insert two suppositories, but at some point during the 12 weeks, active medication is replaced with placebo to allow the drugs to wash out of the body. * Physical examination and blood draw: A physical examination and blood tests are done at the start of the study and several times during the study to assess general health, evaluate liver and kidney function, and measure blood cell counts. * Response to treatment drugs: Responses to Lupron, estrogen, and progesterone are evaluated periodically with interviews and symptoms self-rating scales. Control subjects also take paper and pencil psychological tests. * PET imaging: A total of six PET scans are done at three time points during hormone treatment. PET uses small amounts of a radioactive chemical called a tracer that \"labels\" active areas of the brain. For the procedure, the subject lies on the scanner bed. A special mask is fitted to the head and attached to the bed to help keep the subject's head still during the scan so the images will be clear. A brief scan is done just before the radioactive tracer is injected to help in analyzing the PET data. After the tracer is injected through a catheter (plastic tube) placed in the arm, pictures are taken for about 2 hours, during which the subject lies still on the scanner bed. * MRI scan: MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the patient lies on a table that is moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 1 hour."},
{"id":"NCT00229346","registry":"ClinicalTrials.gov","slug":"fibromyalgia-and-psychiatric-symptoms-among-pms-and-pmdd-nct00229346","match":"direct","title":"Fibromyalgia and Psychiatric Symptoms Among PMS and PMDD Patients","official_title":null,"acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[],"sponsor":"Sheba Medical Center","sponsor_class":"OTHER_GOV","collaborators":[],"countries":["Israel"],"enrollment":null,"enrollment_type":null,"start_date":"2004-10","completion_date":"2006-01","first_posted":"2005-09-29","last_update":"2007-12-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00229346","reference_pmids":[],"brief_summary":"Assessing FM and psychiatric disorder in patients suffering from PMS or PMDD"},
{"id":"ISRCTN48058420","registry":"ISRCTN","slug":"the-effects-of-nutritional-supplementation-on-premenstrual-isrctn48058420","match":"direct","title":"The effects of nutritional supplementation on premenstrual syndrome (PMS)","official_title":null,"acronym":"PMS study","status":"NO_LONGER_RECRUITING","phases":[],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Pre-menstrual syndrome"],"keywords":["Urological and Genital Diseases","Premenstrual syndrome (PMS)"],"interventions":[{"type":"Supplement","name":null}],"sponsor":"Swisse Vitamins Pty Ltd (Australia)","sponsor_class":null,"collaborators":[],"countries":["Australia"],"enrollment":140,"enrollment_type":"ESTIMATED","start_date":"2004-09-01","completion_date":"2005-10-30","first_posted":"2005-09-21","last_update":null,"has_results":false,"results_url":null,"url":"https://www.isrctn.com/ISRCTN48058420","reference_pmids":[],"brief_summary":null},
{"id":"NCT00089414","registry":"ClinicalTrials.gov","slug":"treatment-of-menstrually-related-disorders-with-continuous-v-nct00089414","match":"direct","title":"Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives","official_title":"The Treatment of Menstrually-Related Mood Disorders With Extended Versus Interrupted Oral Contraceptives","acronym":null,"status":"TERMINATED","phases":["PHASE2"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","PMS","Premenstrual Dysphoric Disorder","PMDD","Depression"],"keywords":["Depression","Menstrual Cycle","Gonadal Steroids","Ethinyl Estradiol","Drospirenone","Menstrually Related Mood Disorder","MRMD"],"interventions":[{"type":"DRUG","name":"Ethinyl Estradiol/Drospirenone"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"CDB 2914"}],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":5,"enrollment_type":"ACTUAL","start_date":"2004-07","completion_date":"2010-06","first_posted":"2004-08-05","last_update":"2017-08-25","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00089414?tab=results","url":"https://clinicaltrials.gov/study/NCT00089414","reference_pmids":["2011161","6387488","6686333"],"brief_summary":"This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome (PMDD). Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD. This study will use various treatment regimens with birth control pills and placebo (sugar pill) to clarify the relationships among estrogen and progesterone, the menstrual cycle, and mood. Healthy women between 18 and 45 years of age who menstruate may be eligible for this 15-week study. Candidates are screened with a physical examination, blood and urine tests, an electrocardiogram, and 3 months of symptoms ratings to confirm MRMD. Participants are randomly assigned to one of three treatment groups. Group 1 takes a birth control pill every day and on three occasions takes a placebo capsule. Group 2 takes a birth control pill most but not all days and on three occasions takes a placebo capsule. Group 3 takes a birth control pill every day and on three occasions takes another medication called CDB-2914 that causes menstrual bleeding to occur. Participants come to the NIH clinic every other week for blood tests and measurement of vital signs (blood pressure, pulse, and temperature) and to complete symptoms ratings scales. Subjects who develop breakthrough bleeding (menstruation earlier than expected) will have a transvaginal ultrasound. For this procedure, a probe is inserted into the vagina for about 10 minutes. The probe gives off and receives sound waves that can be used to form a picture of the endometrium (lining of the uterus). ..."},
{"id":"NCT00188396","registry":"ClinicalTrials.gov","slug":"effect-of-the-menstrual-cycle-on-the-symptoms-of-depression-nct00188396","match":"related","title":"Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response","official_title":"The Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response: A Comparison of Premenopausal, Perimenopausal and Postmenopausal Women","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Major Depressive Disorder","Depression"],"keywords":["Major Depressive Disorder","Women's Mental Health","Hormones","Citalopram","Antidepressive agents","Mental Health"],"interventions":[{"type":"DRUG","name":"Citalopram"}],"sponsor":"University Health Network, Toronto","sponsor_class":"OTHER","collaborators":["Ontario Mental Health Foundation"],"countries":["Canada"],"enrollment":44,"enrollment_type":"ACTUAL","start_date":"2004-04","completion_date":"2008-10","first_posted":"2005-09-16","last_update":"2009-03-13","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00188396","reference_pmids":["12920418"],"brief_summary":"Objectives: This prospective investigation will compare premenopausal, perimenopausal and postmenopausal women's response to antidepressant medication. The effects of the menstrual cycle on the symptoms of depression and antidepressant response will also be examined. Hypotheses: Premenopausal women will show a significantly better response to a selective serotonin reuptake inhibitor (SSRI) than peri- or postmenopausal women. Premenopausal women during lower estrogen phases of the menstrual cycle will complain of increased depressive symptoms despite treatment. Perimenopausal and postmenopausal women with irregular periods and generally low estrogen levels will show less symptom variability over time. Method Subjects: Eighty-four women (28 premenopausal, 28 perimenopausal, 28 postmenopausal) meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for major depressive disorder will be enrolled in the study. Procedure: All the subjects will be followed prospectively for 12 weeks and through 2 menstrual cycles while receiving treatment with a standard SSRI antidepressant agent. All eligible women will have a structured clinical interview and will complete questionnaires assessing their depressive symptoms. Blood samples will be collected to evaluate for reproductive hormone levels during the late follicular, midluteal and late luteal phases of the menstrual cycle for two consecutive cycles. Serum SSRI levels will also be collected at these times. As the women in the perimenopausal and postmenopausal groups either have irregular menstrual cycles or no longer cycle, they will have blood samples drawn at baseline and on 6 other occasions. Research Implications: As the majority of psychiatric medication is prescribed to women, understanding the interplay between the menstrual cycle and antidepressant medication will ultimately translate into more diverse and improved patient care. The proposed study is one within a developing research program, which will in part be further guided by this study."},
{"id":"NCT00082043","registry":"ClinicalTrials.gov","slug":"dutasteride-to-treat-women-with-menstrually-related-mood-nct00082043","match":"direct","title":"Dutasteride to Treat Women With Menstrually Related Mood Disorders","official_title":"The Effects of Dutasteride on Mood, HPA Axis, and Serum Allopregnanolone Levels in Women With Menstrual-Related Mood Disorders and Controls","acronym":null,"status":"COMPLETED","phases":["PHASE1"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","PMS","Healthy","Depression"],"keywords":["Neurosteroids","5 Alpha-Reductase Inhibitor","Depression","Menstrual Cycle","Gonadal Steroids","Menstrual Cycle Related Mood Disorder","MRMD","Healthy Volunteer"],"interventions":[{"type":"DRUG","name":"Dutasteride"},{"type":"DRUG","name":"Placebo oral capsule"}],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":34,"enrollment_type":"ACTUAL","start_date":"2004-03-31","completion_date":"2014-03-06","first_posted":"2004-04-28","last_update":"2019-12-17","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00082043","reference_pmids":["11883723","12892987","6362441"],"brief_summary":"This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men. Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up. Participants undergo the following tests and procedures: * Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2 months of placebo. Neither the participants nor the investigators know when the subject is taking the active medication or the placebo. * Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings. * Monthly follow-up visits: Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status."},
{"id":"NCT00183352","registry":"ClinicalTrials.gov","slug":"reproductive-function-and-mood-in-women-with-bipolar-nct00183352","match":"related","title":"Reproductive Function and Mood in Women With Bipolar Disorder","official_title":"Reproductive Endocrine Function and Mood Over the Menstrual Cycle of Women Treated for Bipolar Disorder","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Bipolar Disorder","Mental Health"],"keywords":["Women","Mood","Menarche","Menstruation"],"interventions":[],"sponsor":"Stanford University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":90,"enrollment_type":"ESTIMATED","start_date":"2004-01","completion_date":"2008-07","first_posted":"2005-09-16","last_update":"2014-05-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00183352","reference_pmids":[],"brief_summary":"This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder."},
{"id":"NCT00518570","registry":"ClinicalTrials.gov","slug":"levetiracetam-in-the-treatment-of-patients-with-premenstrual-nct00518570","match":"direct","title":"Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD)","official_title":"A Pilot Study: Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder","acronym":"pmdd","status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder"],"keywords":["PMDD","PMS","Levetiracetam"],"interventions":[{"type":"DRUG","name":"Levetiracetam"}],"sponsor":"Berkshire Health Systems","sponsor_class":"OTHER","collaborators":["UCB Pharma"],"countries":["United States"],"enrollment":7,"enrollment_type":"ACTUAL","start_date":"2003-11","completion_date":"2006-10","first_posted":"2007-08-20","last_update":"2007-08-20","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00518570","reference_pmids":[],"brief_summary":"The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study."},
{"id":"ISRCTN80834259","registry":"ISRCTN","slug":"a-randomised-controlled-trial-of-light-therapy-in-the-isrctn80834259","match":"direct","title":"A randomised controlled trial of light therapy in the treatment of premenstrual syndrome (PMS)","official_title":null,"acronym":null,"status":"NO_LONGER_RECRUITING","phases":[],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Urological and Genital Diseases: Premenstrual syndrome (PMS)"],"keywords":["Urological and Genital Diseases","Premenstrual syndrome (PMS)"],"interventions":[{"type":"Other","name":null}],"sponsor":"Department of Health (UK)","sponsor_class":null,"collaborators":[],"countries":["England","United Kingdom"],"enrollment":0,"enrollment_type":"ESTIMATED","start_date":"2002-06-01","completion_date":"2005-06-01","first_posted":"2003-09-12","last_update":null,"has_results":false,"results_url":null,"url":"https://www.isrctn.com/ISRCTN80834259","reference_pmids":[],"brief_summary":null},
{"id":"ISRCTN94691299","registry":"ISRCTN","slug":"the-effect-of-phytoestrogens-on-symptoms-of-premenstrual-isrctn94691299","match":"direct","title":"The effect of phytoestrogens on symptoms of premenstrual syndrome (PMS) and cognitive performance","official_title":null,"acronym":null,"status":"NO_LONGER_RECRUITING","phases":[],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Urological and Genital Diseases: Premenstrual syndrome (PMS)"],"keywords":["Urological and Genital Diseases","Premenstrual syndrome (PMS)"],"interventions":[{"type":"Drug","name":null}],"sponsor":"Department of Health (UK)","sponsor_class":null,"collaborators":[],"countries":["England","United Kingdom"],"enrollment":50,"enrollment_type":"ESTIMATED","start_date":"2002-04-01","completion_date":"2007-12-31","first_posted":"2003-09-12","last_update":null,"has_results":true,"results_url":"http://www.ncbi.nlm.nih.gov/pubmed/15975174","url":"https://www.isrctn.com/ISRCTN94691299","reference_pmids":[],"brief_summary":null},
{"id":"NCT00318773","registry":"ClinicalTrials.gov","slug":"short-term-versus-long-term-treatment-for-severe-nct00318773","match":"direct","title":"Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)","official_title":"Short-Term Versus Long-Term Treatment for Severe PMS","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["PMS","PMDD","sertraline","antidepressant","extended treatment","relapse"],"interventions":[{"type":"DRUG","name":"sertraline"}],"sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":174,"enrollment_type":"ACTUAL","start_date":"2002-02","completion_date":"2008-02","first_posted":"2006-04-27","last_update":"2009-02-27","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00318773","reference_pmids":["19414713"],"brief_summary":"Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline to determine how long medication should be continued after achieving a good response, how soon symptoms return after stopping medication, and whether symptoms are further improved with long-term treatment. Multiple hypotheses include the following: The percent of relapsed subjects is greater with short-term treatment; relapse is swifter with short-term treatment; relapsed subjects improve swiftly when returned to medication; patient satisfactions and quality of life are more improved with long-term treatment."},
{"id":"NCT00048854","registry":"ClinicalTrials.gov","slug":"antidepressant-treatment-for-premenstrual-syndrome-and-nct00048854","match":"direct","title":"Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder","official_title":"Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder","acronym":null,"status":"COMPLETED","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Sertraline"},{"type":"OTHER","name":"Treatment as usual (TAU)"}],"sponsor":"Yale University","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":66,"enrollment_type":"ACTUAL","start_date":"2001-09","completion_date":"2008-01","first_posted":"2002-11-13","last_update":"2016-01-12","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00048854","reference_pmids":[],"brief_summary":"This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms."},
{"id":"ISRCTN96702191","registry":"ISRCTN","slug":"sleep-and-melatonin-secretion-in-women-with-severe-isrctn96702191","match":"direct","title":"Sleep and melatonin secretion in women with severe premenstrual disorder","official_title":"Sleep and melatonin across the menstrual cycle in women with premenstrual dysphoric disorder (PMDD)","acronym":null,"status":"NO_LONGER_RECRUITING","phases":[],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual dysphoric disorder (PMDD)"],"keywords":["Urological and Genital Diseases","Premenstrual dysphoric disorder (PMDD)"],"interventions":[{"type":"Drug","name":null}],"sponsor":"Douglas Mental Health University Institute (Canada)","sponsor_class":null,"collaborators":[],"countries":["Canada"],"enrollment":18,"enrollment_type":"ESTIMATED","start_date":"2001-01-20","completion_date":"2012-12-31","first_posted":"2011-02-07","last_update":null,"has_results":false,"results_url":null,"url":"https://www.isrctn.com/ISRCTN96702191","reference_pmids":[],"brief_summary":null},
{"id":"NCT00516113","registry":"ClinicalTrials.gov","slug":"a-placebo-controlled-study-to-investigate-the-onset-of-nct00516113","match":"direct","title":"A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria","official_title":"A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder","Premenstrual Syndrome"],"keywords":["paroxetine","onset of action","serotonin reuptake inhibitors"],"interventions":[{"type":"DRUG","name":"paroxetine"}],"sponsor":"Karolinska Institutet","sponsor_class":"OTHER","collaborators":["Novo Nordisk A/S","GlaxoSmithKline","Göteborg University"],"countries":["Sweden"],"enrollment":24,"enrollment_type":"ACTUAL","start_date":"2000-10","completion_date":"2002-11","first_posted":"2007-08-14","last_update":"2007-12-07","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00516113","reference_pmids":[],"brief_summary":"The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder"},
{"id":"NCT00965562","registry":"ClinicalTrials.gov","slug":"comparison-of-fluoxetine-calcium-and-placebo-for-the-nct00965562","match":"direct","title":"Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)","official_title":"A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":"RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","PMS","calcium"],"interventions":[{"type":"DRUG","name":"Fluoxetine"},{"type":"DRUG","name":"Calcium"},{"type":"DRUG","name":"Placebo"}],"sponsor":"Donaghue Medical Research Foundation","sponsor_class":"OTHER","collaborators":["Yale University"],"countries":["United States"],"enrollment":49,"enrollment_type":"ACTUAL","start_date":"2000-09","completion_date":"2010-10","first_posted":"2009-08-25","last_update":"2015-03-23","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00965562?tab=results","url":"https://clinicaltrials.gov/study/NCT00965562","reference_pmids":[],"brief_summary":"The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit."},
{"id":"NCT00005119","registry":"ClinicalTrials.gov","slug":"altered-calcium-and-vitamin-d-in-pmdd-or-severe-pms-nct00005119","match":"direct","title":"Altered Calcium and Vitamin D in PMDD or Severe PMS","official_title":"Altered Calcium And Vitamin D Metabolism in PMDD","acronym":null,"status":"COMPLETED","phases":["NA"],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":"DIAGNOSTIC","conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual Dysphoric Disorder","Severe Premenstrual Syndrome","Calcium metabolism","Vitamin D","Bone Markers","Premenopausal","Menstrual Cycle"],"interventions":[{"type":"PROCEDURE","name":"Measures of calcium and bone turnover"}],"sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsor_class":"NIH","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":null,"enrollment_type":null,"start_date":"2000-05","completion_date":"2003-10","first_posted":"2000-04-20","last_update":"2010-03-02","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00005119","reference_pmids":["2656936","7608284","8199532","9731851"],"brief_summary":"Osteoporosis has become one of the most widely recognized disorders of our times affecting an estimated 25 million women in this country. Recent evidence has suggested that premenstrual syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an important physiological marker of a calcium disturbance. The purpose of this investigation is to understand more completely the extent to which calcium balance is disturbed in severe PMS or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS as it relates to calcium hormones and bone markers. The experimental design involves the comparison between women witn severe PMS and asymptomatic controls."},
{"id":"NCT00005011","registry":"ClinicalTrials.gov","slug":"combined-hormone-replacement-in-menstrually-related-mood-nct00005011","match":"direct","title":"Combined Hormone Replacement in Menstrually-Related Mood Disorders","official_title":"The Treatment of Menstrually-Related Mood Disorders With Continuous Gonadal Steroid Replacement","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Syndrome","Depression"],"keywords":["Depression","Menstrual Cycle","Gonadal Steroids","GnRH Agonist","PMS","Estradiol","Progesterone","Mood","MRMD","PMDD","Menstrually Related Mood Disorders"],"interventions":[],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":22,"enrollment_type":"ACTUAL","start_date":"2000-03-28","completion_date":"2016-10-28","first_posted":"2000-03-30","last_update":"2019-12-16","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00005011","reference_pmids":["2011161","28427285","2962499","9435325"],"brief_summary":"This study investigates the effects on symptoms of combined treatment with estrogen and progesterone in women with severe premenstrual syndrome (PMDD). Studies indicate that women with PMS experience improvement in symptoms following treatment with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but not women without the disorder, experience a return of symptoms within approximately a week after re-exposure to either estrogen or progesterone. The cause of this hormone-induced depression remains unclear. It is not known whether this depressed mood is due simply to the change in the levels of estrogen and progesterone and whether it would remit following continued exposure to stable levels of estrogen and progesterone. This study will determine whether the maintenance of stable hormone levels will prevent mood disturbances in women with PMS. Participants in this study will receive leuprolide acetate injections once a month for up to 6 months. After 2 months, women whose symptoms have improved will receive a skin patch containing either estrogen or placebo (an inactive substance) and will be asked to take daily suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not respond to leuprolide treatment after 2 months will end the study and be offered other treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill out ratings and have blood drawn to measure hormone levels."},
{"id":"NCT00219531","registry":"ClinicalTrials.gov","slug":"effect-of-menstrual-cycle-on-central-nervous-system-cns-nct00219531","match":"related","title":"Effect of Menstrual Cycle on Central Nervous System (CNS) Processing of Gut Stimuli in Irritable Bowel Syndrome (IBS) and Control","official_title":"Effect of Menstrual Cycle and Irritable Bowel Syndrome on the Central Nervous System Processing of Gut Stimuli","acronym":null,"status":"TERMINATED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Irritable Bowel Syndrome"],"keywords":["functional MRI","pain perception","anxiety","brain-gut axis"],"interventions":[{"type":"BEHAVIORAL","name":"perception of rectal balloon distention"}],"sponsor":"Penn State University","sponsor_class":"OTHER","collaborators":["National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","American College of Gastroenterology"],"countries":["United States"],"enrollment":48,"enrollment_type":"ACTUAL","start_date":"1999-03","completion_date":"2015-02","first_posted":"2005-09-22","last_update":"2017-11-29","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00219531","reference_pmids":[],"brief_summary":"The hypothesis of the study is that women perceive intestinal stimulation (rectal balloon distention) differently in different phases of the menstrual cycle, i.e there is an effect of hormones on the sensory pathway, and that this difference is reflected in the Central Nervous System processing of this signal. We also hypothesize that there is a difference in perception between control subjects and subjects with the irritable bowel syndrome."},
{"id":"NCT00678574","registry":"ClinicalTrials.gov","slug":"the-role-of-gaba-and-neurosteroids-in-premenstrual-dysphoric-nct00678574","match":"direct","title":"The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder","official_title":"The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder","acronym":null,"status":"COMPLETED","phases":["PHASE4"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Dysphoric Disorder","Premenstrual Syndrome"],"keywords":["hormones","menses","PMS","PMDD"],"interventions":[{"type":"DRUG","name":"fluoxetine"}],"sponsor":"University of Pennsylvania","sponsor_class":"OTHER","collaborators":["National Institute of Mental Health (NIMH)"],"countries":["United States"],"enrollment":45,"enrollment_type":"ACTUAL","start_date":"1998-03","completion_date":"2008-12","first_posted":"2008-05-15","last_update":"2018-07-27","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00678574?tab=results","url":"https://clinicaltrials.gov/study/NCT00678574","reference_pmids":[],"brief_summary":"The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects."},
{"id":"NCT00001322","registry":"ClinicalTrials.gov","slug":"the-effects-of-reproductive-hormones-on-mood-and-behavior-nct00001322","match":"related","title":"The Effects of Reproductive Hormones on Mood and Behavior","official_title":"The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement","acronym":null,"status":"COMPLETED","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"BASIC_SCIENCE","conditions":["Healthy Volunteers"],"keywords":["Behavior","Brain Function","Progesterone","Central Nervous System Function","gonadotropin-releasing hormone (GnRH) Agonist"],"interventions":[{"type":"DRUG","name":"Leuprolide Acetate 3.75"},{"type":"DRUG","name":"Estradiol"},{"type":"DRUG","name":"Progesterone"},{"type":"DRUG","name":"Placebo suppository"},{"type":"DRUG","name":"Placebo patch"}],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":100,"enrollment_type":"ACTUAL","start_date":"1994-06-09","completion_date":"2020-03-03","first_posted":"1999-11-04","last_update":"2022-03-22","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00001322?tab=results","url":"https://clinicaltrials.gov/study/NCT00001322","reference_pmids":["1324155","28044059","28416813","28786978","30184299","34035477","9238064","9435325"],"brief_summary":"This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies."},
{"id":"NCT00001259","registry":"ClinicalTrials.gov","slug":"a-treatment-study-for-premenstrual-syndrome-pms-nct00001259","match":"direct","title":"A Treatment Study for Premenstrual Syndrome (PMS)","official_title":"The Treatment of Menstrually-Related Mood Disorders With the Gonadotropin Releasing Hormone (GnRH) Agonist, Depot Leuprolide Acetate (Lupron)","acronym":null,"status":"COMPLETED","phases":["PHASE1"],"study_type":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","primary_purpose":"TREATMENT","conditions":["Premenstrual Syndrome","Menstruation Disturbances"],"keywords":["Depression","Menstrual Cycle","Gonadal Steroids","Estradiol","Progesterone","Mood Disorders"],"interventions":[{"type":"DRUG","name":"Leuprolide"},{"type":"DRUG","name":"Estradiol Patches"},{"type":"DRUG","name":"Progesterone"},{"type":"DRUG","name":"Placebo patch"},{"type":"DRUG","name":"Placebo injection"},{"type":"DRUG","name":"Placebo suppository"}],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":60,"enrollment_type":"ACTUAL","start_date":"1992-08-11","completion_date":"2020-02-06","first_posted":"1999-11-04","last_update":"2023-03-02","has_results":true,"results_url":"https://clinicaltrials.gov/study/NCT00001259?tab=results","url":"https://clinicaltrials.gov/study/NCT00001259","reference_pmids":["2011161","28044059","28786978","2962499","30184299","34035477","9435325"],"brief_summary":"This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies."},
{"id":"NCT00001232","registry":"ClinicalTrials.gov","slug":"the-effect-of-gnrh-on-pitutitary-hormones-in-menstrual-cycle-nct00001232","match":"related","title":"The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders","official_title":"Pituitary Gonadotropin Response to GnRH Stimulation in Menstrual, Climacteric and, Menopause-Related Mood and Behavioral Disorders","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Depressive Disorder","Healthy","Mental Disorders","Mood Disorders"],"keywords":["Depression","FSH","GnRH","LH","Menopause","Menstrual Cycle"],"interventions":[],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":140,"enrollment_type":null,"start_date":"1988-07","completion_date":"2000-06","first_posted":"2002-12-10","last_update":"2008-03-04","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00001232","reference_pmids":["2962499","8774283","8828428"],"brief_summary":"The normal menstrual cycle is produced by a series of hormonal signals that starts with the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is located in the brain and is often referred to as the master gland. GnRH then acts on the pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones directly involved in menstruation, estrogen and progesterone. The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones."},
{"id":"NCT00001177","registry":"ClinicalTrials.gov","slug":"study-of-premenstrual-syndrome-and-premenstrual-dysphoria-nct00001177","match":"direct","title":"Study of Premenstrual Syndrome and Premenstrual Dysphoria","official_title":"The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders","acronym":null,"status":"COMPLETED","phases":[],"study_type":"OBSERVATIONAL","allocation":null,"primary_purpose":null,"conditions":["Mood Disorder"],"keywords":["Cognition","Neuroendocrine","PMS Premenstrual Syndrome","MRMD Menstrually Related Mood Disorder","Menstrual"],"interventions":[],"sponsor":"National Institute of Mental Health (NIMH)","sponsor_class":"NIH","collaborators":[],"countries":["United States"],"enrollment":1569,"enrollment_type":"ACTUAL","start_date":"1984-03-09","completion_date":null,"first_posted":"1999-11-04","last_update":"2026-08-18","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00001177","reference_pmids":["1404717","39644712","7906420","9435325"],"brief_summary":"The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS). Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group."},
{"id":"NCT00620581","registry":"ClinicalTrials.gov","slug":"luteal-phase-administration-of-paroxetine-for-the-treatment-nct00620581","match":"direct","title":"Luteal Phase Administration of Paroxetine for the Treatment of PMDD","official_title":"Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women","acronym":"PMDD","status":"COMPLETED","phases":["PHASE3"],"study_type":"INTERVENTIONAL","allocation":null,"primary_purpose":null,"conditions":["Premenstrual Dysphoric Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Paroxetine"}],"sponsor":"Hamilton Health Sciences Corporation","sponsor_class":"OTHER","collaborators":[],"countries":["Canada"],"enrollment":null,"enrollment_type":null,"start_date":null,"completion_date":null,"first_posted":"2008-02-21","last_update":"2008-02-21","has_results":false,"results_url":null,"url":"https://clinicaltrials.gov/study/NCT00620581","reference_pmids":["18517289"],"brief_summary":"The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric disorder has been established. We proposed to test the hypothesis that intermittent treatment with paroxetine administered during the luteal phase of the menstrual cycle only is more effective than placebo in improving symptoms of PMDD. This was a double-blind, placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women 18 years of age or older who met criteria for inclusion in the study were randomized to one of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine 20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of intermittent treatment of paroxetine in women with PMDD."}
]