--- title: A Study of Efficacy and Safety of Sepranolone (UC1 | PMS & PMDD trial description: Completed. Clinical trial on Premenstrual Dysphoric Disorder run by Asarina Pharma in Germany and Poland. url: https://niyora.com/research/trials/a-study-of-efficacy-and-safety-of-sepranolone-uc1010-in-nct03697265/ --- - [Niyora](https://niyora.com/) - [Research](https://niyora.com/research/) - [Clinical trials](https://niyora.com/research/trials/) - A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD) Completed # A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD) 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) Status Completed Registry ID NCT03697265 Type Interventional (tests a treatment) Phase Phase 2 Conditions Premenstrual Dysphoric Disorder What is tested Sepranolone (UC1010) low dose (drug); Sepranolone (UC1010) high dose (drug); Placebo (drug) Sponsor Asarina Pharma Where Germany, Poland, Sweden, United Kingdom Participants 475 Start 2018-04-20 Completion 2020-10-23 Last update 2020-10-28 ## About the study 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. Summary from ClinicalTrials.gov. [See the full record](https://clinicaltrials.gov/study/NCT03697265) Ask AI about this page Copy prompt ChatGPT ↗ Claude ↗ Perplexity ↗ Google AI Mode ↗ Grok ↗