Study of Progesterone in Treatment of Vasomotor Symptoms
Status:
Terminated
Trial end date:
2018-12-06
Target enrollment:
Participant gender:
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).