A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
NCT ID: NCT00924560
Last Updated: 2014-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1361 participants
INTERVENTIONAL
2009-06-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
91-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
Take 1 tablet daily
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).
28-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Untreated Control
Participants received no oral contraceptives during the study.
No interventions assigned to this group
Interventions
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91-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
Take 1 tablet daily
28-day Levonorgestrel Oral Contraceptive
Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
18 Years
FEMALE
Yes
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Principal Investigators
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Jen Henrick
Role: STUDY_CHAIR
Teva GBP
Locations
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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
Countries
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Other Identifiers
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DR-105-202
Identifier Type: -
Identifier Source: org_study_id
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