A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
Status:
Completed
Trial end date:
2020-10-23
Target enrollment:
Participant gender:
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.