Trials / Withdrawn
WithdrawnNCT00117260
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Duramed Research · Industry
- Sex
- Female
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Seasonale (levonorgestrel and ethinyl estradiol) |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2007-07-01
- Completion
- 2007-08-01
- First posted
- 2005-07-06
- Last updated
- 2013-08-12
Source: ClinicalTrials.gov record NCT00117260. Inclusion in this directory is not an endorsement.