Fat Distribution in Healthy Early Postmenopausal Women - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00335218

Purpose

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.

Condition	Intervention	Phase
Healthy Postmenopausal Period	Drug: Estradiol / Dienogest	Phase IV

MedlinePlus related topics: Hormone Replacement Therapy MRI Scans

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Dienogest

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Bayer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Parameters of body composition and lipid metabolism,
Adverse events

Study Start Date:

July 2002

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.

Eligibility

Ages Eligible for Study:	48 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy early postmenopausal women, aged 48-60 years, with BMI between 25 and 30

Exclusion Criteria:

Contra-indication(s) for hormone treatment, metabolic diseases, concomitant medication with influence on lipid metabolism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335218

Locations

Austria

Vienna, Austria, A-1090

Vienna, Austria, A-1060

Vienna, Austria, A-1200

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

+ 49 30 46811800

More Information

Study ID Numbers:	306387
Study First Received:	February 24, 2006
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00335218
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Bayer:

(Early) postmenopausal state with climacteric symptoms (need for hormone replacement therapy)

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Estradiol 17 beta-cypionate
Healthy

Polyestradiol phosphate
Estradiol
Dienogest

Additional relevant MeSH terms:

Estrogens
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral

Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009