3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women (NCT00310531) | Clinical Trial Compass
CompletedPhase 3
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
500 participantsStarted 2004-02
Plain-language 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 prevention and treatment of osteoporosis.
Who can participate
Age range55 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Last (regular) menstrual period more than 5 years ago
* Relative good state of health
* Intact, normal uterus
Exclusion Criteria:
* 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)
What they're measuring
1
Percentage change in Bone Mineral Density at the lumbar spine