Fat Distribution in Healthy Early Postmenopausal Women

Bayer

Status and phase: Completed; Phase 4

Conditions: Healthy; Postmenopause

Treatments: Drug: Placebo; Drug: Climodien / Lafamme (BAY86-5027)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00335218

91161

306387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: Female

Ages: 48 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Climodien / Lafamme (BAY86-5027)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo