Overview

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)