NCT00924560

A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females

A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of DR-105 and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,361 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.

Detailed description

Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for each study participant will be approximately 13 months.

Conditions

• Bone Mineral Density

Interventions

Type	Name	Description
DRUG	91-day Levonorgestrel Oral Contraceptive	Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily
DRUG	28-day Levonorgestrel Oral Contraceptive	Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-06-19
• Last updated: 2014-10-22
• Results posted: 2014-10-09

Locations

46 sites across 1 country: United States