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

Information source: Agile Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: AG200-15 transdermal patch (Drug); Oral Contraceptive (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Agile Therapeutics

Official(s) and/or principal investigator(s):
Marie Foegh, MD, DrSc, Study Director, Affiliation: Agile Therapeutics

Summary

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Pregnancy

Detailed description: 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).

Eligibility

Minimum age: 17 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

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, Tuscon, 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, Boyton 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

Additional Information

Starting date: August 2010
Last updated: January 30, 2013

Page last updated: August 23, 2015

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