DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteopenia

Intervention: Menostar (Estradiol, BAY86-5435) (Drug); Raloxifene (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Percentage change in Bone Mineral Density at the lumbar spine

Secondary outcome:

Percentage change in Bone Mineral Density of the hip

Percentage change in biochemical markers of bone turnover

Proportion of patients with hot flushes

Change in Women's Health Questionnaire

Proportion of patients with an abnormal endometrial biopsy

Pharmacogenetic analysis

Digital breast density analysis

Detailed 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.

Eligibility

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.

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)

Locations and Contacts

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: February 2004
Last updated: December 29, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017