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)
1 other identifier
interventional
475
4 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2018
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2018
CompletedFirst Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedOctober 28, 2020
October 1, 2020
2.3 years
September 28, 2018
October 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Starting from first dose given until 1 months after treatment stop
Study Arms (3)
Sepranolone (UC1010) low dose
EXPERIMENTALSepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase
Sepranolone (UC1010) high dose
EXPERIMENTALSepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase
Placebo
PLACEBO COMPARATORPlacebo administered subcutaneously (SC) during the luteal phase
Interventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asarina Pharmalead
- Ergomedcollaborator
Study Sites (12)
Zentrum für Klinische Forschnung
Bad Homburg, Germany
Emovis
Berlin, Germany
Medizentrum Essen Borbeck
Essen, Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Germany
Praxis Dr. Steinwachs
Nuremberg, Germany
Centrum Kliniczno-Badawcze
Elblag, Poland
Centrum Medyczne Angelius Provita
Katowice, Poland
ProCreative
Krakow, Poland
Karolinska University Hospital
Stockholm, 17176, Sweden
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, ST4 6QG, United Kingdom
Related Publications (1)
Bixo M, Ekberg K, Poromaa IS, Hirschberg AL, Jonasson AF, Andreen L, Timby E, Wulff M, Ehrenborg A, Backstrom T. Treatment of premenstrual dysphoric disorder with the GABAA 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.
PMID: 28319848BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaughn O'Brien, MD
Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 5, 2018
Study Start
April 20, 2018
Primary Completion
July 28, 2020
Study Completion
October 23, 2020
Last Updated
October 28, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share