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

Premenstrual Dysphoric Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697265
• Other study ID #: UM203
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2018
• Est. completion date: October 23, 2020

Study information

• Verified date: October 2020
• Source: Asarina Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: October 23, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder

Intervention

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

Locations

Country	Name	City	State
Germany	Zentrum für Klinische Forschnung	Bad Homburg
Germany	Emovis	Berlin
Germany	Medizentrum Essen Borbeck	Essen
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe
Germany	Praxis Dr. Steinwachs	Nürnberg
Poland	Centrum Kliniczno-Badawcze	Elblag
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	ProCreative	Kraków
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	Liverpool Women's NHS Foundation Trust	Liverpool
United Kingdom	Imperial College London	London
United Kingdom	Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire	Stoke-on-Trent

Sponsors (2)

Lead Sponsor	Collaborator
Asarina Pharma	Ergomed

Countries where clinical trial is conducted

Germany,  Poland,  Sweden,  United Kingdom, 

References & Publications (1)

Bixo M, Ekberg K, Poromaa IS, Hirschberg AL, Jonasson AF, Andréen L, Timby E, Wulff M, Ehrenborg A, Bäckström T. Treatment of premenstrual dysphoric disorder with the GABA(A) receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial. Psychoneuroendocrinology. 2017 Jun;80:46-55. doi: 10.1016/j.psyneuen.2017.02.031. Epub 2017 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on DRSP Total symptom score	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	Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment.
Secondary	Incidence of Treatment-Emergent Adverse Events	Recording of adverse events	Starting from first dose given until 1 months after treatment stop