Conditions: Contraception
Keywords: Contraceptive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1504
Healthy volunteers: yes

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).

Arms:
arm 1: AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug. arm 2: Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.

Interventions: intervention 1: AG200-15 (cycles 1-13) intervention 2: Lessina crossover to AG200-15
Intervention descriptions: intervention 1: AG200-15 containing ethinyl estradiol and levonorgestrel intervention 2: Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.

Protocol document: