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NCT00335218 Clinical Trial

Fat Distribution in Healthy Early Postmenopausal Women

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00335218
Other study ID # 91161
Secondary ID 306387
Status Completed
Phase Phase 4
First received February 24, 2006
Last updated December 29, 2014
Start date July 2002
Est. completion date August 2004

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 48 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Climodien / Lafamme (BAY86-5027)
1 tablet daily (2 mg EV + 2 mg DNG)
• Placebo
1 tablet daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Individual relative change of abdominal visceral fat measured by magnetic resonance imaging Baseline and after 24 weeks of treatment
Secondary Parameters of body composition and lipid metabolism Baseline and after 24 weeks of treatment
Secondary Adverse events collection During whole study period
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