3-year study of Menostar versus Evista to prevent osteoporosis in post-menopausal women
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.
- Last (regular) menstrual period more than 5 years ago - Relative good state of health - Intact, normal uterus
- 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)
A Multicenter, Double-Blind, Double-Dummy, Randomized, Active- Controlled, 3-Year Study to Evaluate the Antiresorptive Efficacy, Safety and Tolerability of a Ultra-Low Dose Estradiol Transdermal Delivery System Releasing 0.014 mg / Day Versus Oral Raloxifene Hydrochloride 60 mg / Day - as a Therapy for the Prevention of Osteoporosis in Postmenopausal Female Osteopenic Patients.