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

October 10, 2014 updated by: Duramed Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1361

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Teva Investigational Site 007
      • Phoenix, Arizona, United States
        • Teva Investigational Site 018
      • Tucson, Arizona, United States
        • Teva Investigational Site 005
    • Arkansas
      • North Little Rock, Arkansas, United States
        • Teva Investigational Site 047
    • California
      • La Mesa, California, United States
        • Teva Investigational Site 027
      • Los Angeles, California, United States
        • Teva Investigational Site 040
      • Mountain View, California, United States
        • Teva Investigational Site 037
      • San Diego, California, United States
        • Teva Investigational Site 013
      • San Diego, California, United States
        • Teva Investigational Site 017
      • Torrance, California, United States
        • Teva Investigational Site 025
    • District of Columbia
      • Washington, District of Columbia, United States
        • Teva Investigational Site 022
    • Florida
      • Boynton Beach, Florida, United States
        • Teva Investigational Site 004
      • Clearwater, Florida, United States
        • Teva Investigational Site 008
      • DeLand, Florida, United States
        • Teva Investigational Site 026
      • Miami, Florida, United States
        • Teva Investigational Site 001
      • Miami, Florida, United States
        • Teva Investigational Site 003
      • Tampa, Florida, United States
        • Teva Investigational Site 028
      • West Palm Beach, Florida, United States
        • Teva Investigational Site 041
    • Illinois
      • Champaign, Illinois, United States
        • Teva Investigational Site 034
    • Kentucky
      • Louisville, Kentucky, United States
        • Teva Investigational Site 023
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Teva Investigational Site 021
    • Missouri
      • St. Louis, Missouri, United States
        • Teva Investigational Site 030
    • Nebraska
      • Lincoln, Nebraska, United States
        • Teva Investigational Site 009
    • New Jersey
      • Lawrenceville, New Jersey, United States
        • Teva Investigational Site 010
    • New York
      • Port Jefferson, New York, United States
        • Teva Investigational Site 038
      • Rochester, New York, United States
        • Teva Investigational Site 048
    • North Carolina
      • Durham, North Carolina, United States
        • Teva Investigational Site 002
      • Kernersville, North Carolina, United States
        • Teva Investigational Site 043
      • New Bern, North Carolina, United States
        • Teva Investigational Site 044
      • Raleigh, North Carolina, United States
        • Teva Investigational Site 020
      • Winston-Salem, North Carolina, United States
        • Teva Investigational Site 006
    • Ohio
      • Cleveland, Ohio, United States
        • Teva Investigational Site 033
    • Oregon
      • Medford, Oregon, United States
        • Teva Investigational Site 012
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Teva Investigational Site 035
      • Pottstown, Pennsylvania, United States
        • Teva Investigational Site 039
    • Rhode Island
      • Providence, Rhode Island, United States
        • Teva Investigational Site 036
    • South Carolina
      • Charleston, South Carolina, United States
        • Teva Investigational Site 032
      • Columbia, South Carolina, United States
        • Teva Investigational Site 024
    • Texas
      • Dallas,, Texas, United States
        • Teva Investigational Site 046
      • Houston, Texas, United States
        • Teva Investigational Site 031
      • Houston, Texas, United States
        • Teva Investigational Site 045
      • Waco, Texas, United States
        • Teva Investigational Site 011
    • Utah
      • Salt Lake City, Utah, United States
        • Teva Investigational Site 015
    • Virginia
      • Norfolk, Virginia, United States
        • Teva Investigational Site 019
    • Washington
      • Seattle, Washington, United States
        • Teva Investigational Site 014
      • Spokane, Washington, United States
        • Teva Investigational Site 016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 91-day Levonorgestrel Oral Contraceptive
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).
Drug: 91-day Levonorgestrel Oral Contraceptive

Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.

Take 1 tablet daily

Other Names:
  • levonorgestrel/ethinyl estradiol
  • Seasonique®
  • DR-105
Active Comparator: 28-day Levonorgestrel Oral Contraceptive
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).
Drug: 28-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Other Names:
  • levonorgestrel/ethinyl estradiol
  • Lessina®
No Intervention: Untreated Control
Participants received no oral contraceptives during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)
Time Frame: Baseline and Month 12

Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.

Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline * 100%.
Baseline and Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Lumbar Spine Bone Mineral Density
Time Frame: Baseline, Month 6 and Month 12
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Baseline, Month 6 and Month 12
Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)
Time Frame: Baseline, Month 6 and Month 12
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Density
Time Frame: Baseline, Month 6 and Month 12
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Baseline, Month 6 and Month 12
Change From Baseline in Proximal Femur Bone Mineral Content (BMC)
Time Frame: Baseline, Month 6 and Month 12
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Density
Time Frame: Baseline, Month 6 and Month 12
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.
Baseline, Month 6 and Month 12
Change From Baseline in Total Body Bone Mineral Content (BMC)
Time Frame: Baseline, Month 6 and Month 12
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.
Baseline, Month 6 and Month 12
Change From Baseline in Bone-specific Alkaline Phosphatase
Time Frame: Baseline, Month 6 and Month 12
Baseline, Month 6 and Month 12
Change From Baseline in Serum Deoxypyridinoline
Time Frame: Baseline, Month 6 and Month 12
Baseline, Month 6 and Month 12
Change From Baseline in Serum Osteocalcin
Time Frame: Baseline, Month 6 and Month 12
Baseline, Month 6 and Month 12
Change From Baseline in Serum Procollagen 1 N-terminal Propeptide
Time Frame: Baseline, Month 6 and Month 12
Baseline, Month 6 and Month 12
Change From Baseline in Serum Type I Collagen N-telopeptide
Time Frame: Baseline, Month 6 and Month 12
Baseline, Month 6 and Month 12
Number of Participants With Adverse Events (AEs)
Time Frame: 12 months

An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.

A severe AE is defined as incapacitating, with inability to perform usual activities.

A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:

  • fatal or life-threatening;
  • required or prolonged inpatient hospitalization;
  • resulted in persistent or significant disability/incapacity;
  • congenital anomaly or birth defect;
  • important medical event.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Investigators

  • Study Chair: Jen Henrick, Teva GBP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (Estimate)

June 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-105-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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