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
1 other identifier
interventional
1,361
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Typical duration for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
October 9, 2014
CompletedOctober 22, 2014
October 1, 2014
3.2 years
June 18, 2009
October 3, 2014
October 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (3)
91-day Levonorgestrel Oral Contraceptive
EXPERIMENTALParticipants 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).
28-day Levonorgestrel Oral Contraceptive
ACTIVE COMPARATORParticipants 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).
Untreated Control
NO INTERVENTIONParticipants received no oral contraceptives during the study.
Interventions
Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (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
Teva Investigational Site 022
Washington D.C., 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY CHAIR
Jen Henrick
Teva GBP
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2009
First Posted
June 19, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 22, 2014
Results First Posted
October 9, 2014
Record last verified: 2014-10