Conditions: Healthy
Keywords: PK and safety Pharmacokinetic profile (PK) and safety
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: yes

Brief summary:
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.

Detailed description:
This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).

Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).

Arms:
arm 1: Ortho-Cyclen® is a comparator drug intervention arm 2: AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

Interventions: intervention 1: Ortho-Cyclen intervention 2: AG200-15
Intervention descriptions: intervention 1: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen. intervention 2: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Protocol document: