Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System



Status:Completed
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:17 - 40
Updated:7/5/2018
Start Date:August 2010
End Date:March 2012

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Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy,
cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG.
To evaluate TCDS wearability (including adhesion).

Inclusion Criteria:

Healthy females

- 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:

- Known or suspected pregnancy;

- 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
We found this trial at
80
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Saint Petersburg, Florida 33709
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Akron, OH
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Atlanta, Georgia
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Bedford, TX
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Boulder, Colorado
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Boynton Beach, Florida 33472
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Cary, North Carolina
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Champaign, Illinois
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Champaign, IL
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Chandler, Arizona
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Charlotte, North Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbus, OH
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Corpus Christi, Texas
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Corpus Christi, TX
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Dallas, TX
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Daytona Beach, Florida
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Decatur, Georgia
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Decatur, GA
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Deland, Florida
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Deland, FL
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Denver, Colorado
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Edison, New Jersey
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Englewood, Ohio
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Englewood, OH
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Fort Collins, Colorado
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Fort Myers, Florida
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Green Valley, Arizona
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Houston, TX
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Huntsville, Alabama
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Indianapolis, Indiana
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Jackson, Tennessee
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Jacksonville, Florida
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Kernersville, North Carolina
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Knoxville, Tennessee
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Lexington, Kentucky
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Little Rock, Arkansas
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Los Angeles, California
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Marrero, Louisiana
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Mayfield Heights, Ohio
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Medford, Oregon
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Mobile, Alabama
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