NCT03697265

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Asarina Pharma · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used. The study will also include a follow-up (no treatment) cycle before patients final visit. The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.

Conditions

• Premenstrual Dysphoric Disorder

Interventions

Type	Name	Description
DRUG	Sepranolone (UC1010) low dose	Subcutaneous (SC) administration
DRUG	Sepranolone (UC1010) high dose	Subcutaneous (SC) administration
DRUG	Placebo	Subcutaneous (SC) adminstration

Timeline

• Start date: 2018-04-20
• Primary completion: 2020-07-28
• Completion: 2020-10-23
• First posted: 2018-10-05
• Last updated: 2020-10-28

Locations

12 sites across 4 countries: Germany, Poland, Sweden, United Kingdom