Status:
COMPLETED
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
Lead Sponsor:
Bayer
Conditions:
Osteopenia
Eligibility:
FEMALE
55-80 years
Phase:
PHASE3
Brief Summary
The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for preventio...
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 Criteria
Inclusion
- Last (regular) menstrual period more than 5 years ago
- Relative good state of health
- Intact, normal uterus
Exclusion
- Bone and musculoskeletal diseases
- Clinically significant vertebral fracture within the last 12 months
- Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
- Uncontrolled diabetes mellitus (or treated with insulin)
- Uncontrolled thyroid disorders
- Relevant renal disorder or significant liver dysfunction (including cholestasis)
- History of alcohol or drug abuse
- History of immobilization of more than 2 months in the last 6 months
- Smoking of more than 10 cigarettes per day
- Unexplained uterine bleeding
- Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00310531
Start Date
February 1 2004
End Date
June 1 2007
Last Update
December 30 2014
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