drugset / Trial / NCT00117260

Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

NCT00117260

Phase 3 Withdrawn Duramed Research
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

Drugs

EvaluationDrugModalityDoseRoute
Subject Levonorgestrel Small molecule Oral
Subject ethinyl estradiol Small molecule Oral

Indications

No indication recorded.