Trials / Terminated
TerminatedNCT03202186
Study of Progesterone in Treatment of Vasomotor Symptoms
Double-Blind Trial Investigating the Efficacy of Different Doses of Progesterone Compared With Placebo for Treatment of Vasomotor Symptoms
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- BHR Pharma, LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Progesterone oral capsule | Oral capsule treatment |
| DRUG | Placebo oral capsule | Oral capsule treatment |
Timeline
- Start date
- 2017-08-01
- Primary completion
- 2018-12-06
- Completion
- 2018-12-06
- First posted
- 2017-06-28
- Last updated
- 2019-03-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03202186. Inclusion in this directory is not an endorsement.