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

Sponsors

Lead Sponsor: Duramed Research

Source Teva Pharmaceutical Industries
Brief 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.

Overall Status Completed
Start Date 2009-06-01
Completion Date 2012-08-01
Primary Completion Date 2012-08-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) Baseline and Month 12
Secondary Outcome
Measure Time Frame
Change From Baseline in Lumbar Spine Bone Mineral Density Baseline, Month 6 and Month 12
Change From Baseline in Lumbar Spine Bone Mineral Content (BMC) Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Density Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Content (BMC) Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Density Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Content (BMC) Baseline, Month 6 and Month 12
Change From Baseline in Bone-specific Alkaline Phosphatase Baseline, Month 6 and Month 12
Change From Baseline in Serum Deoxypyridinoline Baseline, Month 6 and Month 12
Change From Baseline in Serum Osteocalcin Baseline, Month 6 and Month 12
Change From Baseline in Serum Procollagen 1 N-terminal Propeptide Baseline, Month 6 and Month 12
Change From Baseline in Serum Type I Collagen N-telopeptide Baseline, Month 6 and Month 12
Number of Participants With Adverse Events (AEs) 12 months
Enrollment 1361
Condition
Intervention

Intervention Type: Drug

Intervention Name: 91-day Levonorgestrel Oral Contraceptive

Description: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily

Arm Group Label: 91-day Levonorgestrel Oral Contraceptive

Intervention Type: Drug

Intervention Name: 28-day Levonorgestrel Oral Contraceptive

Description: Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Arm Group Label: 28-day Levonorgestrel Oral Contraceptive

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

12 Years

Maximum Age:

18 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jen Henrick Study Chair Teva GBP
Location
Facility:
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
Teva Investigational Site 022 | Washington, District of Columbia, United States
Teva Investigational Site 004 | Boynton Beach, Florida, United States
Teva Investigational Site 008 | Clearwater, Florida, United States
Teva Investigational Site 026 | DeLand, Florida, United States
Teva Investigational Site 001 | Miami, Florida, United States
Teva Investigational Site 003 | Miami, Florida, United States
Teva Investigational Site 028 | Tampa, Florida, United States
Teva Investigational Site 041 | West Palm Beach, Florida, United States
Teva Investigational Site 034 | Champaign, Illinois, United States
Teva Investigational Site 023 | Louisville, Kentucky, United States
Teva Investigational Site 021 | Baton Rouge, Louisiana, United States
Teva Investigational Site 030 | St. Louis, Missouri, United States
Teva Investigational Site 009 | Lincoln, Nebraska, United States
Teva Investigational Site 010 | Lawrenceville, New Jersey, United States
Teva Investigational Site 038 | Port Jefferson, New York, United States
Teva Investigational Site 048 | Rochester, New York, United States
Teva Investigational Site 002 | Durham, North Carolina, United States
Teva Investigational Site 043 | Kernersville, North Carolina, United States
Teva Investigational Site 044 | New Bern, North Carolina, United States
Teva Investigational Site 020 | Raleigh, North Carolina, United States
Teva Investigational Site 006 | Winston-Salem, North Carolina, United States
Teva Investigational Site 033 | Cleveland, Ohio, United States
Teva Investigational Site 012 | Medford, Oregon, United States
Teva Investigational Site 035 | Pittsburgh, Pennsylvania, United States
Teva Investigational Site 039 | Pottstown, Pennsylvania, United States
Teva Investigational Site 036 | Providence, Rhode Island, United States
Teva Investigational Site 032 | Charleston, South Carolina, United States
Teva Investigational Site 024 | Columbia, South Carolina, United States
Teva Investigational Site 046 | Dallas,, Texas, United States
Teva Investigational Site 031 | Houston, Texas, United States
Teva Investigational Site 045 | Houston, Texas, United States
Teva Investigational Site 011 | Waco, Texas, United States
Teva Investigational Site 015 | Salt Lake City, Utah, United States
Teva Investigational Site 019 | Norfolk, Virginia, United States
Teva Investigational Site 014 | Seattle, Washington, United States
Teva Investigational Site 016 | Spokane, Washington, United States
Location Countries

United States

Verification Date

2014-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: 91-day Levonorgestrel Oral Contraceptive

Type: Experimental

Description: Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).

Label: 28-day Levonorgestrel Oral Contraceptive

Type: Active Comparator

Description: Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).

Label: Untreated Control

Type: No Intervention

Description: Participants received no oral contraceptives during the study.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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