Pharmacokinetics of norelgestromin and ethinyl estradiol from two consecutive contraceptive patches.
The primary objective of this open-label study was to determine the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE)following two consecutive applications of a contraceptive patch (ORTHO EVRA/EVRA). Twelve healthy women wore the first patch on their abdomen for 7 days and, after removal at 168 hours (day 7), wore a second patch for 10 days (i.e., 3 days beyond the intended 7-day wear period). Blood samples were collected before and at various times up to 456 hours (day 19) after application of the first patch for analysis of NGMN and EE. Mean serum concentrations of NGMN and EE remained within the reference ranges, 0.6 to 1.2 ng/ml and 25 to 75 pg/ml, respectively, during the entire 7-day wear period after application of the first patch and for 10 days after application of the second patch; reference ranges are based on studies with ORTHO-CYCLEN/ Cilest. No patch detached spontaneously. No subject discontinued or experienced a serious adverse event.
Abrams
L S
LS
The R. W Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869, USA.
Skee
D M
DM
Wong
F A
FA
Anderson
N J
NJ
Leese
P T
PT
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D004338:Drug Combinations; D045166:Estradiol Congeners / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D013997:Time Factors
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D045166:Estradiol Congeners; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D005003:Ethisterone; C449219:norelgestromin