Status:
COMPLETED
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Lead Sponsor:
Agile Therapeutics
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief 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.
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 seru...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT01236768
Start Date
October 1 2010
End Date
June 1 2011
Last Update
September 15 2017
Active Locations (21)
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1
Mobile, Alabama, United States, 36608
2
Green Valley, Arizona, United States, 85614
3
Tucson, Arizona, United States, 85712
4
Los Angeles, California, United States, 90036