Trial Search Results

A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in 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 currently not accepting patients for this trial.

Lead Sponsor:

Duramed Research

Intervention(s):

  • Drug: 91-day Levonorgestrel Oral Contraceptive
  • Drug: 28-day Levonorgestrel Oral Contraceptive

Phase:

Phase 2

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

Ages Eligible for Study

12 Years - 18 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kelsey Lynd
6507211237
Not Recruiting