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

Trial ID or NCT#

NCT00924560

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 12 Years to 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Neville H. Golden M.D.
Paula Hillard
Paula Hillard
Pediatric/adolescent gynecologist
Professor of Obstetrics and Gynecology (General Gynecology), Emerita

Contact us to find out if this trial is right for you.

Contact

Kelsey Lynd
6507211237

View on ClinicalTrials.gov