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Study of Progesterone in Treatment of Vasomotor Symptoms

NCT03202186 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-03-06

No results posted yet for this study

Summary

The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in postmenopausal women. Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be tested against placebo in hierarchical order, starting with the highest dose. Superiority will be defined as a significant (significance level α = 0.05) reduction of moderate to severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint of the study).

Conditions

  • Menopause Related Conditions

Interventions

DRUG

Progesterone oral capsule

Oral capsule treatment

DRUG

Placebo oral capsule

Oral capsule treatment

Sponsors & Collaborators

  • BHR Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Head of Clinical Development, PhD · BESINS Healthcare Ireland Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-12-06
Completion
2018-12-06

Countries

  • Germany

Study Locations

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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 NCT03202186 on ClinicalTrials.gov