Fat Distribution in Healthy Early Postmenopausal Women

December 29, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
      • Wien, Austria, 1060
      • Wien, Austria, 1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
Time Frame: Baseline and after 24 weeks of treatment
Baseline and after 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Parameters of body composition and lipid metabolism
Time Frame: Baseline and after 24 weeks of treatment
Baseline and after 24 weeks of treatment
Adverse events collection
Time Frame: During whole study period
During whole study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 9, 2006

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 91161
  • 306387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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