check_circleStudy Completed

Healthy, Postmenopause

Bayer Identifier:

91161

ClinicalTrials.gov Identifier:

NCT00335218

EudraCT Number:

Not Available

EU CT Number:

Not Available
Fat distribution in healthy early postmenopausal women

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.

Key Participants Requirements

Sex

Female

Age

48 - 60 Years
  • - Healthy early postmenopausal women
    - BMI between 25 and 30
  • - Contra-indication(s) for hormone treatment
    - Metabolic diseases
    - Concomitant medication with influence on lipid metabolism

Trial summary

Enrollment Goal
67
Trial Dates
July 2002 - August 2004
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Climodien, Lafamme (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dr. Ewald BoschitschWien, 1060, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Dr. Wolfgang BartlWien, 1200, Austria

Primary Outcome

  • Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
    date_rangeTime Frame:
    Baseline and after 24 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Parameters of body composition and lipid metabolism
    date_rangeTime Frame:
    Baseline and after 24 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None
  • Adverse events collection
    date_rangeTime Frame:
    During whole study period
    enhanced_encryption
    Safety Issue:
    None

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.