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

NCT03697265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2020-10-28

No results posted yet for this study

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.

Conditions

  • Premenstrual Dysphoric Disorder

Interventions

DRUG

Sepranolone (UC1010) low dose

Subcutaneous (SC) administration

DRUG

Sepranolone (UC1010) high dose

Subcutaneous (SC) administration

DRUG

Placebo

Subcutaneous (SC) adminstration

Sponsors & Collaborators

  • Ergomed

    collaborator INDUSTRY

  • Asarina Pharma

    lead INDUSTRY

Principal Investigators

  • Shaughn O'Brien, MD · Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2020-07-28
Completion
2020-10-23

Countries

  • Germany
  • Poland
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03697265 on ClinicalTrials.gov