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OpenTrials
Completed

NCT Number: NCT00335218

Fat Distribution in 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.

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Key information

Conditions

Healthy Postmenopause

Age range

48 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Vienna, State of Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Climodien / Lafamme (BAY86-5027)

Drug

1 tablet daily (2 mg EV + 2 mg DNG)

Placebo

Drug

1 tablet daily

Primary outcomes

  1. Individual relative change of abdominal visceral fat measured by magnetic resonance imaging

    Time frame: Baseline and after 24 weeks of treatment

Secondary outcomes

  1. Parameters of body composition and lipid metabolism

    Time frame: Baseline and after 24 weeks of treatment

  2. Adverse events collection

    Time frame: During whole study period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2004
First posted
Jun 9, 2006
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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