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
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : 28-day Levonorgestrel Oral Contraceptive
- drug : 91-day Levonorgestrel Oral Contraceptive
Phase: Phase 2
Ages Eligible For Study:
- Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating - Regular spontaneous menstrual cycles - Body mass index (BMI): 18 kg/mē to <30 kg/mē, weight < 200 lbs - Others as dictated by the Food and Drug Administration (FDA)-approved protocol