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

• Status: Withdrawn
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research
• Treatments: Estradiol; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel

Criteria

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