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

Completed · Phase 3

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT01236768

Run by

Agile Therapeutics

People needed

407

Starts

2010-10-01

Expected to finish

2011-06-01

Last updated by the study team

2017-09-15

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Green Valley, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — West Hills, California, United States
• Study site — Boynton Beach, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Newburgh, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Kernersville, North Carolina, United States
• Study site — Englewood, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Corpus Christi, Texas, United States
• Study site — Sugar Land, Texas, United States
• Study site — Newport News, Virginia, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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