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

Bayer

Status and phase

Completed

Phase 3

Conditions

Osteopenia

Treatments

Drug: Raloxifene

Drug: Menostar (Estradiol, BAY86-5435)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00310531

91213

306871

Details and patient eligibility

About

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.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment

500 patients

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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)