Trial Condition(s):

Osteopenia

3-year study of Menostar versus Evista to prevent osteoporosis in post-menopausal women

Bayer Identifier:

91213

ClinicalTrials.gov Identifier:

NCT00310531

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
500
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Menostar (E2 transdermal, BAY86-5435)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design