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.
Overview
- Phase
- Phase 3
- Intervention
- AG200-15 (cycles 1-13)
- Conditions
- Contraception
- Sponsor
- Agile Therapeutics
- Enrollment
- 1504
- Locations
- 2
- Primary Endpoint
- Pregnancy
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 TCDS wearability (including adhesion).
Investigators
Eligibility Criteria
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
Arms & Interventions
AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
Intervention: AG200-15 (cycles 1-13)
Lessina crossover to AG200-15
Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
Intervention: Lessina crossover to AG200-15
Outcomes
Primary Outcomes
Pregnancy
Time Frame: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Pregnancy outcomes was determine by measuring Pearl index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.