drugset / Trial / NCT03202186
Study of Progesterone in Treatment of Vasomotor Symptoms
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2017-08-01
- Primary completion
- 2018-12-06
- Completion
- 2018-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 200 mg | Oral |
| Subject | Progesterone | Other / unclassified | 300 mg | Oral |
| Subject | Progesterone | Other / unclassified | 400 mg | Oral |
Indications
No indication recorded.