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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
Purpose
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
Professor of Obstetrics and Gynecology (General Gynecology), Emerita
Eligibility
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
contraceptives
- Use of any medication which could significantly interfere with study assessments
- Others as dictated by FDA-approved protocol
Intervention(s):
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
6507211237