Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
NCT ID: NCT01236768
Last Updated: 2017-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
407 participants
INTERVENTIONAL
2010-10-31
2011-06-30
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
PREVENTION
NONE
Study Groups
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AG200-15
Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
AG200-15
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Levora
oral contraceptive containing 150mcg of LNG and 30mcg of EE
Levora
One tablet of Levora will be taken each day for a 28 day cycle.
Interventions
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AG200-15
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Levora
One tablet of Levora will be taken each day for a 28 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular menses every 24 - 35 days
* In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values
Exclusion Criteria
* Lactating women
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
18 Years
40 Years
FEMALE
Yes
Sponsors
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Agile Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Marie Foegh, MD
Role: STUDY_DIRECTOR
Agile Therapeutics
Locations
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Mobile, Alabama, United States
Green Valley, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
West Hills, California, United States
Boynton Beach, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Newburgh, Indiana, United States
Louisville, Kentucky, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Kernersville, North Carolina, United States
Englewood, Ohio, United States
Tulsa, Oklahoma, United States
Mt. Pleasant, South Carolina, United States
Corpus Christi, Texas, United States
Sugar Land, Texas, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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ATI-CL13
Identifier Type: -
Identifier Source: org_study_id
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