Conditions: Bone Mineral Density
Keywords: Adolescents Bone Mineral Density Oral Contraceptive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1361
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). arm 2: Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). arm 3: Participants received no oral contraceptives during the study.

Interventions: intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: 28-day Levonorgestrel Oral Contraceptive
Intervention descriptions: intervention 1: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.

Take 1 tablet daily intervention 2: Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Protocol document: