Conditions: Contraception
Keywords: Contraceptive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 407
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, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Arms:
arm 1: Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) arm 2: oral contraceptive containing 150mcg of LNG and 30mcg of EE

Interventions: intervention 1: AG200-15 intervention 2: Levora
Intervention descriptions: intervention 1: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period. intervention 2: One tablet of Levora will be taken each day for a 28 day cycle.

Protocol document: