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

NCT ID: NCT03697265

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2020-10-23

Brief Summary

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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

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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

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Premenstrual Dysphoric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sepranolone (UC1010) low dose

Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase

Group Type EXPERIMENTAL

Sepranolone (UC1010) low dose

Intervention Type DRUG

Subcutaneous (SC) administration

Sepranolone (UC1010) high dose

Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase

Group Type EXPERIMENTAL

Sepranolone (UC1010) high dose

Intervention Type DRUG

Subcutaneous (SC) administration

Placebo

Placebo administered subcutaneously (SC) during the luteal phase

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous (SC) adminstration

Interventions

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Sepranolone (UC1010) low dose

Subcutaneous (SC) administration

Intervention Type DRUG

Sepranolone (UC1010) high dose

Subcutaneous (SC) administration

Intervention Type DRUG

Placebo

Subcutaneous (SC) adminstration

Intervention Type DRUG

Eligibility Criteria

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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,

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ergomed

INDUSTRY

Sponsor Role collaborator

Asarina Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaughn O'Brien, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire

Locations

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Zentrum für Klinische Forschnung

Bad Homburg, , Germany

Site Status

Emovis

Berlin, , Germany

Site Status

Medizentrum Essen Borbeck

Essen, , Germany

Site Status

Klinische Forschung Karlsruhe GmbH

Karlsruhe, , Germany

Site Status

Praxis Dr. Steinwachs

Nuremberg, , Germany

Site Status

Centrum Kliniczno-Badawcze

Elblag, , Poland

Site Status

Centrum Medyczne Angelius Provita

Katowice, , Poland

Site Status

ProCreative

Krakow, , Poland

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Liverpool Women's NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Imperial College London

London, , United Kingdom

Site Status

Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire

Stoke-on-Trent, , United Kingdom

Site Status

Countries

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Germany Poland Sweden United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 28319848 (View on PubMed)

Other Identifiers

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UM203

Identifier Type: -

Identifier Source: org_study_id