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

Not Recruiting

Trial ID: NCT00924560


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.

Official Title

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

Stanford Investigator(s)

Paula Hillard
Paula Hillard

Professor of Obstetrics and Gynecology (General Gynecology), Emerita


Inclusion Criteria:

   - Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating

   - Regular spontaneous menstrual cycles

   - Body mass index (BMI): 18 kg/m² to <30 kg/m², weight < 200 lbs

   - Others as dictated by the Food and Drug Administration (FDA)-approved protocol

Exclusion Criteria:

   - Any contraindication to the use of oral contraceptives

   - History of previous clinically significant adverse event while taking hormonal

   - Use of any medication which could significantly interfere with study assessments

   - Others as dictated by FDA-approved protocol


drug: 91-day Levonorgestrel Oral Contraceptive

drug: 28-day Levonorgestrel Oral Contraceptive

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kelsey Lynd