Fat Distribution in Healthy Early Postmenopausal Women

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335218

Enrollment

Registered

2006-06-09

Start date

2002-07-31

Completion date

2004-08-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Postmenopause

Keywords

Early postmenopausal state, Climacteric symptoms, Hormone replacement therapy

Brief 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.

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.

Interventions

DRUGClimodien / Lafamme (BAY86-5027)

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

DRUGPlacebo

1 tablet daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

48 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026