Conditions: Healthy
Keywords: PK and safety Pharmacokinetic profile (PK) and safety
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
This is a pharmacokinetics and safety study over 3 weekly applications.

Detailed description:
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).

Arms:
arm 1: Patch was placed on abdomen, buttock then the upper torso excluding breast.

Intervention: AG200-15 patch arm 2: Patch was placed on abdomen, upper torso excluding breast then the buttock.

Intervention: AG200-15 patch arm 3: Patch was placed on the buttock, abdomen, then the upper torso excluding breast.

Intervention: AG200-15 patch arm 4: Patch was placed on the buttock, upper torso excluding breast then the abdomen

Intervention: AG200-15 patch arm 5: Patch was placed on the upper torso excluding breast, abdomen then buttock.

Intervention: AG200-15 patch arm 6: Patch was place on the upper torso excluding breast, buttock, then abdomen.

Intervention: AG200-15 patch

Interventions: intervention 1: AG200-15
Intervention descriptions: intervention 1: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Protocol document: