3-Year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-Menopausal Women
Information source: Bayer
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia
Intervention: Menostar (SH P00577 E) (Drug)
Phase: Phase 3
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs, Study Director, Affiliation: T. +49 30 468 11800
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.
Official title: 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.
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage change in Bone Mineral Density at the lumbar spine
Percentage change in Bone Mineral Density at the hip
Percentage change in biochemical markers of bone turnover
Proportion of patients with hot flushes
Women's Health Questionnaire
Proportion of patients with an abnormal endometrial biopsy
Digital breast density analysis
Time Frame for all secondary outcomes: 3 years (3 x 13 cycles à 28 days)
Number of arms: 2
1. (MENOSTAR PATCH) SH P00577 E: Transdermal system (TDS) worn for 1 week and SH K00718 P:
placebo capsules (containing placebo tablet) or
2. (MENOSTAR PLACEBO PATCH) SH P00577 PE: Matching placebo patch and (Evista) SH K00718 A
containing a raloxifene hydrochloride 60 mg tablet)
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.
Minimum age: 55 Years.
Maximum age: 80 Years.
- 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,
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Starting date: February 2004
Ending date: June 2007
Last updated: October 11, 2007