Multiple-dose pharmacokinetics of a contraceptive patch in healthy women participants.
This open-label, randomized study evaluated the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE) following the application of a contraceptive patch (1/week) for three cycles (3 weeks/cycle). Healthy women (n = 24) wore a 20-cm(2) patch (ORTHO EVRA/EVRA) on either their abdomen or buttock during blood sampling weeks and on any of four approved sites at other times. Serum was analyzed for NGMN and EE from samples taken during Week 1 of Cycle 1 and Weeks 1-3 of Cycle 3. Steady-state conditions were achieved during the three-cycle study. The patch delivered NGMN and EE at steady-state concentrations within their reference ranges throughout three cycles of treatment; reference ranges are based on studies with ORTHO-CYCLEN/Cilest. Steady-state serum concentrations and area under the curve from 0 to 168 h increased only slightly from Cycle 1, Week 1 to Cycle 3, Week 3 for NGMN and EE, indicating minimal accumulation. Treatment was well tolerated, and patch adhesion was excellent.
Abrams
L S
LS
The R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ, USA. labrams@prius.jnj.com
Skee
D M
DM
Natarajan
J
J
Wong
F A
FA
Lasseter
K C
KC
D000279:Administration, Cutaneous; D000328:Adult; D000704:Analysis of Variance; D003271:Contraceptive Agents, Female / Q000097:blood* / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000097:blood* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000031:analogs & derivatives* / Q000097:blood / Q000494:pharmacology* / Q000627:therapeutic use*; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives* / Q000097:blood* / Q000627:therapeutic use*; D010091:Oximes; D013997:Time Factors
D003271:Contraceptive Agents, Female; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; C017576:norgestimate; C449219:norelgestromin