Trials / Completed
CompletedNCT00310531
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Menostar (Estradiol, BAY86-5435) | Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day) |
| DRUG | Raloxifene | Raloxifene tbl. (60 mg/day) |
Timeline
- Start date
- 2004-02-01
- Completion
- 2007-06-01
- First posted
- 2006-04-04
- Last updated
- 2014-12-30
Source: ClinicalTrials.gov record NCT00310531. Inclusion in this directory is not an endorsement.