Status:
COMPLETED
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Lead Sponsor:
Agile Therapeutics
Conditions:
Contraception
Eligibility:
FEMALE
17-40 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, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCD...
Eligibility Criteria
Inclusion
- 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
- 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 :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
1504 Patients enrolled
Trial Details
Trial ID
NCT01181479
Start Date
August 1 2010
End Date
March 1 2012
Last Update
July 3 2018
Active Locations (80)
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1
Agile Investigational Site
Huntsville, Alabama, United States, 35801
2
Agile Investigational Site
Mobile, Alabama, United States, 36608
3
Agile Investigational Site
Chandler, Arizona, United States, 85224
4
Agile Investigational Site
Green Valley, Arizona, United States, 85614