Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra (TM)/Evra (TM)) under conditions of heat, humidity, and exercise

The objectives of this randomized, open-label, three-period, incomplete blo ck design study. were to evaluate the pharmacokinetics of norelgestromin (N GMN) and ethinyl estradiol (EE) delivered by the contraceptive patch, Ortho Evra (TM) /Evra (TM), and to evaluate patch adhesion under conditions of h eat, humidity, and exercise. During each treatment period, 30 healthy women wore Ortho Evra (TM) on the abdomen for 7 days under one of six conditions (normal activity, sauna, whirlpool, treadmill, cool water immersion, or a combination of activities). Blood samples were collected before and several times to 240 hours after patch application. Mean serum concentrations of N GMN and EE generally remained within the reference ranges, 0.6 to 1.2 ng/ml and 25 to 75 pg/ml, respectively, during the 7-day wear period for all act ivities. Only 1 (1.1%) of 87 patches completely detached spontaneously. Pee l force measurements were comparable for all activities. Ortho Evra (TM) wa s well tolerated. In conclusion, Ortho Evra (TM) delivers efficacious conce ntrations of NGMN and EE and maintains adhesive reliability through 7 days of wear even under conditions of heat, humidity, and exercise. (C) 2001 the American College of Clinical Pharmacology.