CompletedNCT00335218Updated Dec 30, 2014

Fat Distribution in Healthy Early Postmenopausal Women

A Phase 4 interventional study of Climodien / Lafamme (BAY86-5027) and Placebo in Healthy and Postmenopause, sponsored by Bayer. Completed at 3 sites in Austria. Open to female participants aged 48 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Bayer · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 67
Allocation: Randomized
Ages: 48 Years to 60 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Healthy
Postmenopause

Keywords

Early postmenopausal state
Climacteric symptoms
Hormone replacement therapy

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 48 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy early postmenopausal women
BMI between 25 and 30

Exclusion criteria

Exclusion Criteria:

Contra-indication(s) for hormone treatment
Metabolic diseases
Concomitant medication with influence on lipid metabolism

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 67 participants (actual)

Study arms

Experimental
Arm 1
Drug: Climodien / Lafamme (BAY86-5027)
Placebo comparator
Arm 2
Drug: Placebo

Interventions

DrugClimodien / Lafamme (BAY86-5027)
1 tablet daily (2 mg EV + 2 mg DNG)
DrugPlacebo
1 tablet daily

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

3 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00335218
Lead sponsor: Bayer
Responsible party: Sponsor
First posted: Jun 9, 2006
Start date: Jul 2002
Completion: Aug 2004
Last update: Dec 30, 2014

Study contacts

Bayer Study Director

study director · Bayer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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