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.