Trials / Completed
CompletedNCT00335218
Fat Distribution in Healthy Early Postmenopausal Women
A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 48 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Climodien / Lafamme (BAY86-5027) | 1 tablet daily (2 mg EV + 2 mg DNG) |
| DRUG | Placebo | 1 tablet daily |
Timeline
- Start date
- 2002-07-01
- Completion
- 2004-08-01
- First posted
- 2006-06-09
- Last updated
- 2014-12-30
Locations
3 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT00335218. Inclusion in this directory is not an endorsement.