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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


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

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