Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
NCT ID: NCT00196326
Last Updated: 2016-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2235 participants
INTERVENTIONAL
2005-06-30
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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DR-1011
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
DR-1011
Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Interventions
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DR-1011
Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not pregnant or breastfeeding
* Sexually active at risk of pregnancy
Exclusion Criteria
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day
18 Years
40 Years
FEMALE
Yes
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Duramed Research, Inc.
Principal Investigators
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Duramed Protocol Chair
Role: STUDY_CHAIR
Duramed Research, Inc.
Locations
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Duramed Investigational Site
Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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San Diego, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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New London, Connecticut, United States
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Coral Cables, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Palm Springs, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Decatur, Georgia, United States
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Douglasville, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lawrenceville, New Jersey, United States
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Moorestown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Lakewood, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
Countries
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References
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Kroll R, Reape KZ, Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. Contraception. 2010 Jan;81(1):41-8. doi: 10.1016/j.contraception.2009.07.003.
Other Identifiers
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DR-PSE-309
Identifier Type: -
Identifier Source: org_study_id