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Fat Distribution in Healthy Early Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00335218
First received: February 24, 2006
Last updated: April 16, 2009
Last verified: April 2009
History of Changes
  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.


Condition Intervention Phase
Healthy
Postmenopause
 Drug: Climodien / Lafamme (BAY86-5027)
Drug: Placebo
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Individual relative change of abdominal visceral fat measured by magnetic resonance imaging [ Time Frame: Baseline and after 24 weeks of treatment ]

Secondary Outcome Measures:
  • Parameters of body composition and lipid metabolism [ Time Frame: Baseline and after 24 weeks of treatment ]
  • Adverse events collection [ Time Frame: During whole study period ]

Enrollment: 70
Study Start Date: July 2002
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Climodien / Lafamme (BAY86-5027)
1 tablet daily (2 mg EV + 2 mg DNG)
Placebo Comparator: Arm 2 Drug: Placebo
1 tablet daily

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.

  Eligibility

Ages Eligible for Study:   48 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335218

Locations
Austria
Wien, Austria, 1060
Wien, Austria, 1200
Wien, Austria, 1090
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00335218     History of Changes
Other Study ID Numbers: 91161, 306387
Study First Received: February 24, 2006
Last Updated: April 16, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Bayer:
Early postmenopausal state
Climacteric symptoms
Hormone replacement therapy

Additional relevant MeSH terms:
Estradiol Valerate, dienogest drug combination
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2012