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Study of Progesterone in Treatment of Vasomotor Symptoms — PROGEST  

Menopause Related Conditions Clinical Trial

Official title:
Double-Blind Trial Investigating the Efficacy of Different Doses of Progesterone Compared With Placebo for Treatment of Vasomotor Symptoms

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03202186
Study type Interventional
Source BHR Pharma, LLC
Contact
Status Terminated
Phase Phase 3
Start date August 1, 2017
Completion date December 6, 2018
View Details
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