A Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

April 20, 2018

Estimated Primary Completion Date

November 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effect on DRSP Total symptom score[ Time Frame: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment (average of 3 menstrual cycles). ]

Change in DRSP Total symptom score (Daily Record of Severity of Problems) measured during the luteal phase (i.e. the week before menstruation) before and during treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Incidence of Treatment-Emergent Adverse Events[ Time Frame: Starting from first dose given until 1 months after treatment stop ]
Recording of adverse events

Descriptive Information

Brief Title ^ICMJE

A Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

Official Title ^ICMJE

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)

Brief 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 225 to 250 patients.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Sepranolone (UC1010) low dose
Subcutaneous (SC) administration
Drug: Sepranolone (UC1010) high dose
Subcutaneous (SC) administration
Drug: Placebo
Subcutaneous (SC) adminstration

Study Arms

Experimental: Sepranolone (UC1010) low dose
Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase
Experimental: Sepranolone (UC1010) high dose
Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase
Placebo Comparator: Placebo
Placebo administered subcutaneously (SC) during the luteal phase

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

225

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 28, 2020

Estimated Primary Completion Date

November 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Asarina Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Shaughn O'Brien, MD Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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