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: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asarina Pharma
• Collaborator: Ergomed
• Treatments: Pregnanolone

Criteria

Main Inclusion Criteria:

• have PMDD according to DSM-5 verified in two menstrual cycles

• have a regular menstrual cycle of 24-35 days cycle,

• use double barrier contraception, non-hormonal IUD, be truly sexually abstinent, or subject or her partner has been surgically sterilized,

Main Exclusion Criteria:

• steroid hormonal treatment or treatment with psychopharmaceuticals during previous three months

• treatments for premenstrual syndrome (PMS) or PMDD

• history of or significant medical condition ongoing

• be pregnant or plan a pregnancy within the study period