Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
Phase 3
Withdrawn
- Conditions
- Osteopenia
- Registration Number
- NCT00117260
- Lead Sponsor
- Duramed Research
- Brief Summary
This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. The duration of the study for each patient will be approximately two years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Not sexually active and agree to remain sexually inactive throughout the course of the study
- First menstrual period at least one year ago
- No menstrual period in the last 6 months
Exclusion Criteria
- Undiagnosed abnormal genital bleeding
- Known or suspected pregnancy
- Medical history of any disorder that contraindicates the use of oral contraceptives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean percent change in the lumbar spine bone mineral density at month 12
- Secondary Outcome Measures
Name Time Method Change in body weight Mean percent change in the proximal femur (hip) bone mineral density Mean percent change in total body bone mineral density Mean change in biochemical markers of bone resorption and bone formation Interim and 24 month mean percent change in lumbar spine bone mineral density