Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
NCT ID: NCT01181479
Last Updated: 2018-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1504 participants
INTERVENTIONAL
2010-08-31
2012-03-31
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
PREVENTION
NONE
Study Groups
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AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel
Lessina crossover to AG200-15
Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
Lessina crossover to AG200-15
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Interventions
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AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel
Lessina crossover to AG200-15
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active women requesting birth control
* In good general health, confirmed by medical history, physical (including gynecologic) examination and 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
17 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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Elizabeth Garner, MD, MPH
Role: STUDY_DIRECTOR
Agile Therapeutics
Locations
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Agile Investigational Site
Huntsville, Alabama, United States
Agile Investigational Site
Mobile, Alabama, United States
Agile Investigational Site
Chandler, Arizona, United States
Agile Investigational Site
Green Valley, Arizona, United States
Agile Investigational Site
Tucson, Arizona, United States
Agile Investigational Site
Little Rock, Arkansas, United States
Agile Investigational Site
La Mesa, California, United States
Agile Investigational Site
Los Angeles, California, United States
Agile Investigational
Sacramento, California, United States
Agile Investigational Site
San Diego, California, United States
Agile Investigational Site
Santa Ana, California, United States
Agile Investigational Site
Vista, California, United States
Agile Investigational Site
West Hills, California, United States
Agile Investigational Site
Boulder, Colorado, United States
Agile Investigational Site
Colorado Springs, Colorado, United States
Agile Investigational Site
Denver, Colorado, United States
Agile Investigational Site
Fort Collins, Colorado, United States
Agile Investigational Site
Wheat Ridge, Colorado, United States
Agile Investigational Site
Milford, Connecticut, United States
Agile Investigational Site
New London, Connecticut, United States
Agile Investigational Site
Waterbury, Connecticut, United States
Agile Investigational Site
Boynton Beach, Florida, United States
Agile Investigational Site
Clearwater, Florida, United States
Agile Investigational Site
Daytona Beach, Florida, United States
Agile Investigational Site
DeLand, Florida, United States
Agile Investigational Site
Fort Myers, Florida, United States
Agile Investigational Site
Jacksonville, Florida, United States
Agile Investigational Site
Pinellas Park, Florida, United States
Agile Investigational Site
South Miami, Florida, United States
Agile Investigational Site
St. Petersburg, Florida, United States
Agile Investigational Site
West Palm Beach, Florida, United States
Agile Investigational Site
Atlanta, Georgia, United States
Agile Investigational Site
Decatur, Georgia, United States
Agile Investigational Site
Sandy Springs, Georgia, United States
Agile Investigational Site
Champaign, Illinois, United States
Agile Investigational Site
Chicago, Illinois, United States
Agile Investigational Site
Indianapolis, Indiana, United States
Agile Investigational Site
Newburgh, Indiana, United States
Agile Investigational Site
Overland Park, Kansas, United States
Agile Investigational Site
Wichita, Kansas, United States
Agile Investigational Site
Lexington, Kentucky, United States
Agile Investigational Site
Louisville, Kentucky, United States
Agile Investigational Site
Marrero, Louisiana, United States
Agile Investigational Site
Lincoln, Nebraska, United States
Agile Investigational Site
Las Vegas, Nevada, United States
Agile Investigational Site
Edison, New Jersey, United States
Agile Investigational Site
Lawrenceville, New Jersey, United States
Agile Investigational Site
Rochester, New York, United States
Agile Investigational Site
Cary, North Carolina, United States
Agile Investigational Site
Charlotte, North Carolina, United States
Agile Investigational Site
Kernersville, North Carolina, United States
Agile Investigational Site
Raleigh, North Carolina, United States
Agile Investigational Site
Salisbury, North Carolina, United States
Agile Investigational Site
Wilmington, North Carolina, United States
Agile Investigational Site
Winston-Salem, North Carolina, United States
Agile Investigational Site
Akron, Ohio, United States
Agile Investigational Site
Cincinnati, Ohio, United States
Agile Investigational Site
Cleveland, Ohio, United States
Agile Investigational Site
Columbus, Ohio, United States
Agile Investigational Site
Englewood, Ohio, United States
Agile Investigational Site
Mayfield Heights, Ohio, United States
Agile Investigational Site
Oklahoma City, Oklahoma, United States
Agile Investigational Site
Tulsa, Oklahoma, United States
Agile Investigational Site
Medford, Oregon, United States
Agile Investigational Site
Jackson, Tennessee, United States
Agile Investigational Site
Knoxville, Tennessee, United States
Agile Investigational Site
Memphis, Tennessee, United States
Agile Investigational Site
Austin, Texas, United States
Agile Investigational Site
Bedford, Texas, United States
Agile Investigational Site
Corpus Christi, Texas, United States
Agile Investigational Site
Dallas, Texas, United States
Agile Investigational Site
Houston, Texas, United States
Agile Investigational Site
San Antonio, Texas, United States
Agile Investigational Site
Sugar Land, Texas, United States
Agile Investigational Site
Webster, Texas, United States
Agile Investigational Site
Salt Lake City, Utah, United States
Agile Investigational Site
Newport News, Virginia, United States
Agile Investigational Site
Norfolk, Virginia, United States
Agile Investigational Site
Richmond, Virginia, United States
Agile Investigational Site
Seattle, Washington, United States
Countries
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References
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Kaunitz AM, Portman D, Westhoff CL, Mishell DR Jr, Archer DF, Foegh M. New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception. 2015 Mar;91(3):211-6. doi: 10.1016/j.contraception.2014.11.013. Epub 2014 Nov 25.
Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Foegh M. Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill. Contraception. 2015 Mar;91(3):204-10. doi: 10.1016/j.contraception.2014.11.011. Epub 2014 Nov 25.
Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Rubin A, Foegh M. Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):295-303. doi: 10.1097/AOG.0000000000000095.
Other Identifiers
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57731
Identifier Type: OTHER
Identifier Source: secondary_id
ATI-CL12
Identifier Type: -
Identifier Source: org_study_id
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