Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra/Evra) under conditions of heat, humidity, and exercise.
The objectives of this randomized, open-label, three-period, incomplete block design study were to evaluate the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE) delivered by the contraceptive patch, Ortho Evra/Evra, and to evaluate patch adhesion under conditions of heat, humidity, and exercise. During each treatment period, 30 healthy women wore Ortho Evra 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 NGMN 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 wearperiodfor all activities. Only 1 (1.1%) of 87 patches completely detached spontaneously. Peel force measurements were comparable for all activities. Ortho Evra was well tolerated. In conclusion, Ortho Evra delivers efficacious concentrations of NGMN and EE and maintains adhesive reliability through 7 days of wear even under conditions of heat, humidity, and exercise.
Abrams
L S
LS
The R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869, USA.
Skee
D M
DM
Natarajan
J
J
Wong
F A
FA
Leese
P T
PT
Creasy
G W
GW
Shangold
M M
MM
D000268:Adhesiveness; D000279:Administration, Cutaneous; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D004338:Drug Combinations; D045166:Estradiol Congeners / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D005003:Ethisterone / Q000031:analogs & derivatives; D015444:Exercise / Q000502:physiology*; D005260:Female; D006358:Hot Temperature; D006801:Humans; D006813:Humidity; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D045166:Estradiol Congeners; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D005003:Ethisterone; C449219:norelgestromin