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COMPLETEDPHASE2

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

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

NCT00924560•Duramed Research

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for each study participant will be approximately 13 months.

Eligibility

Age

12 - 18 years

Sex

FEMALE

Healthy Volunteers

Yes

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

Locations (46)

Teva Investigational Site 007

Phoenix, Arizona, United States

Teva Investigational Site 018

Phoenix, Arizona, United States

Teva Investigational Site 005

Tucson, Arizona, United States

Teva Investigational Site 047

North Little Rock, Arkansas, United States

Teva Investigational Site 027

La Mesa, California, United States

Teva Investigational Site 040

Los Angeles, California, United States

Teva Investigational Site 037

Mountain View, California, United States

Teva Investigational Site 013

San Diego, California, United States

Teva Investigational Site 017

San Diego, California, United States

Teva Investigational Site 025

Torrance, California, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

October 22, 2014

Enrollment

1,361

ACTUAL participants

Conditions

Bone Mineral Density

Interventions

91-day Levonorgestrel Oral Contraceptive

DRUG

28-day Levonorgestrel Oral Contraceptive

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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