The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women

• NGMN plasma concentrations (Periods 1 and 2) [ Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. ] [ Designated as safety issue: No ]
  
• EE plasma concentrations (Periods 1 and 2) [ Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. ] [ Designated as safety issue: No ]
  

• Pharmacokinetic parameters of NGMN (Periods 1 and 2) [ Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. ] [ Designated as safety issue: No ]
  Pharmacokinetic parameters of NGMN as measured by AUC, Cmax, tmax, and Css.
  
  
• Pharmacokinetic parameters of EE (Periods 1 and 2) [ Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. ] [ Designated as safety issue: No ]
  Pharmacokinetic parameters of EE as measured by AUC, Cmax, tmax, and Css.
  
  
• Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
  
• The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
  

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), single-center, single-application, 2-way crossover study (participants receive different interventions sequentially during the trial) of ORTHO EVRA with and without an adhesive overlay. ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl estradiol (EE). The participants will be randomly assigned to 1 of 2 possible treatment sequences to ensure that they receive both of the following treatments, 1 in each period: - Treatment A: ORTHO EVRA patch applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system; - Treatment B: ORTHO EVRA patch applied to the buttock without an overlay. The study consists of a screening phase; an open-label treatment phase consisting of 2 single-application 7-day treatment periods; and end-of-study or withdrawal assessments done upon completion of the 240-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal. Pharmacokinetic evaluations explore how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The two treatment periods will be separated by a washout period (period when receiving no treatment) of 21 days. During the study, safety and tolerability will also be assessed. The total duration of participation in the study for an individual will be approximately 2 months.