Trial Condition(s):
Healthy, Postmenopause
Fat distribution in healthy early postmenopausal women
Bayer Identifier:
91161
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Healthy early postmenopausal women - BMI between 25 and 30
Exclusion Criteria
- Contra-indication(s) for hormone treatment - Metabolic diseases - Concomitant medication with influence on lipid metabolism
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Dr. Ewald Boschitsch Wien, Austria, 1060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Wolfgang Bartl Wien, Austria, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Individual relative change of abdominal visceral fat measured by magnetic resonance imagingTimeframe: Baseline and after 24 weeks of treatment
Secondary Outcome
- Parameters of body composition and lipid metabolismTimeframe: Baseline and after 24 weeks of treatment
- Adverse events collectionTimeframe: During whole study period
Additional Information
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