drugset / Trial / NCT00117260
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2005-07
- Primary completion
- 2007-07
- Completion
- 2007-08
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levonorgestrel | Small molecule | — | Oral |
| Subject | ethinyl estradiol | Small molecule | — | Oral |
Indications
No indication recorded.