Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Status: | Completed |
---|---|
Conditions: | Contraception, Contraception |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 17 - 40 |
Updated: | 7/5/2018 |
Start Date: | August 2010 |
End Date: | March 2012 |
Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
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.
contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
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 TCDS wearability (including adhesion).
cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG.
To evaluate TCDS wearability (including adhesion).
Inclusion Criteria:
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 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
We found this trial at
80
sites
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