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

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

NCT01181479

Run by

Agile Therapeutics

People needed

1504

Starts

2010-08-01

Expected to finish

2012-03-01

Last updated by the study team

2018-07-03

Who can join

Age: 17 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

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

• 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 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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