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Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

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: Study Drug AG200-15, Contraceptives, Hormonal (Drug); Levora, Contraceptives, Oral, Hormonal (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Agile Therapeutics

Official(s) and/or principal investigator(s):
Marie Foegh, MD, 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: An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System (TCDS) in Comparison to an Oral Contraceptive Containing 150 Mcg Levonorgestrel And 30 Mcg Ethinyl Estradiol

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, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- sexually active women requesting contraception

- Regular menses every 24 - 35 days

- In good general health, confirmed by medical history, physical (including gynecologic

examination adn 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

Mobile, Alabama 36608, United States

Green Valley, Arizona 85614, United States

Tucson, Arizona 85712, United States

Los Angeles, California 90036, United States

Los Angeles, California 90057, United States

West Hills, California 91307, United States

Boynton Beach, Florida 33472, United States

South Miami, Florida 33143, United States

St. Petersburg, Florida 33709, United States

Newburgh, Indiana 47630, United States

Louisville, Kentucky 40291, United States

Las Vegas, Nevada 89109, United States

Las Vegas, Nevada 89128, United States

Kernersville, North Carolina 27284, United States

Englewood, Ohio 45322, United States

Tulsa, Oklahoma 74105, United States

Mt. Pleasant, South Carolina 29464, United States

Corpus Christi, Texas 78414, United States

Sugar Land, Texas 77479, United States

Newport News, Virginia 23606, United States

Norfolk, Virginia 23502, United States

Additional Information

Starting date: October 2010
Last updated: January 28, 2013

Page last updated: August 23, 2015

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