Research

Bone Mineral Density Effects of DR-105 – Phase II

A 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

Protocol Description

The purpose of this multi-center study is to determine the effect of two oral hormonal contraceptives on bone mineral density over a 12-month period. The study will compare girls not using any hormones to a study group whose members use hormonal contraceptives provided in either a standard 28-day regimen or in a 91-day regimen of DR-105 (the study drug). Both regimens are approved for use as birth control; however the purpose of this study is to look at their effects on teen girls' bones. The Adolescent Clinic is currently only enrolling girls for the study groups that will be taking birth control pills.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to girls, ages 12 through 18 who are seeking treatment with hormonal contraceptives for birth control or for some other reason, such as menstrual cramps, acne, etc.
Girls: Ages 12 through 18

Requirements
Participants will be randomized into groups that will take the study drug DR-105 or the 28-day oral contraceptive, whose results will be compared to the control group. Participants will be given physical exams, including blood draws and urine samples, as well as a DXA scans, a type of X-ray that measures the amount of calcium in bones. They will also be required to keep diaries of their medication use and health changes.
Visits: 5 visits and 10 telephone calls
Duration: 13 months

Status: Closed to Enrollment

Source(s) of Support
Teva Women’s Health Research, Inc.

Additional Information
Study Description at National Institutes of Health