ClinicalTrials.gov
ClinicalTrials.gov Menu

Fat Distribution in Healthy Early Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00335218
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Healthy Postmenopause Drug: Climodien / Lafamme (BAY86-5027) Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2002
Actual Study Completion Date : August 2004

Arm Intervention/treatment
Experimental: Arm 1 Drug: Climodien / Lafamme (BAY86-5027)
1 tablet daily (2 mg EV + 2 mg DNG)

Placebo Comparator: Arm 2 Drug: Placebo
1 tablet daily




Primary Outcome Measures :
  1. Individual relative change of abdominal visceral fat measured by magnetic resonance imaging [ Time Frame: Baseline and after 24 weeks of treatment ]

Secondary Outcome Measures :
  1. Parameters of body composition and lipid metabolism [ Time Frame: Baseline and after 24 weeks of treatment ]
  2. Adverse events collection [ Time Frame: During whole study period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   48 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335218


Locations
Austria
Wien, Austria, 1060
Wien, Austria, 1090
Wien, Austria, 1200
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00335218     History of Changes
Other Study ID Numbers: 91161
306387
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Early postmenopausal state
Climacteric symptoms
Hormone replacement therapy

Additional relevant MeSH terms:
Estradiol Valerate, dienogest drug combination
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs