Status unknown
Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?
Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.
- Status
- Status unknown
- Registry ID
- NCT02562053
- Type
- Interventional (tests a treatment)
- Phase
- Phase 3
- Conditions
- Premenstrual Syndrome
- What is tested
- Fluoxetine (drug); Combined oral contraceptives (drug); Placebo 1 (drug); Placebo 2 (drug)
- Sponsor
- Cairo University
- Where
- Egypt
- Participants
- 300 (planned)
- Start
- 2015-10
- Completion
- 2017-09
- Last update
- 2016-07-06
About the study
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.
Summary from ClinicalTrials.gov.