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Fat Distribution in Healthy Early Postmenopausal Women

NCT ID: NCT00335218

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-08-31

Brief Summary

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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

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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

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Healthy Postmenopause

Keywords

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Early postmenopausal state Climacteric symptoms Hormone replacement therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Climodien / Lafamme (BAY86-5027)

Intervention Type DRUG

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

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet daily

Interventions

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Climodien / Lafamme (BAY86-5027)

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

Intervention Type DRUG

Placebo

1 tablet daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

48 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Vienna, Vienna, Austria

Site Status

Vienna, , Austria

Site Status

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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306387

Identifier Type: -

Identifier Source: secondary_id

91161

Identifier Type: -

Identifier Source: org_study_id