NCT00335218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Jul 2002

Typical duration for phase_4 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

February 24, 2006

Last Update Submit

December 29, 2014

Conditions

HealthyPostmenopause

Keywords

Early postmenopausal stateClimacteric symptomsHormone replacement therapy

Outcome Measures

Primary Outcomes (1)

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

    Baseline and after 24 weeks of treatment

Secondary Outcomes (2)

  • Parameters of body composition and lipid metabolism

    Baseline and after 24 weeks of treatment

  • Adverse events collection

    During whole study period

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Climodien / Lafamme (BAY86-5027)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Climodien / Lafamme (BAY86-5027)DRUG

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

Arm 1
PlaceboDRUG

1 tablet daily

Arm 2

Eligibility Criteria

Age48 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy early postmenopausal women
  • BMI between 25 and 30

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Vienna, Vienna, 1090, Austria

Location

Unknown Facility

Vienna, 1060, Austria

Location

Unknown Facility

Vienna, 1200, Austria

Location

MeSH Terms

Interventions

estradiol valerate-dienogest

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2006

First Posted

June 9, 2006

Study Start

July 1, 2002

Study Completion

August 1, 2004

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

AU(3)