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

Duramed Research

Status and phase: Withdrawn; Phase 3

Conditions: Osteopenia

Treatments: Drug: Seasonale (levonorgestrel and ethinyl estradiol)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117260

SEA-305

Details and patient eligibility

About

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.

Sex: Female

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind