3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Raloxifene Hydrochloride

Criteria

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)