Multiple-dose pharmacokinetics of a contraceptive patch in healthy women participants

Contraception. 2001 Nov;64(5):287-94. doi: 10.1016/s0010-7824(01)00273-6.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Analysis of Variance
  • Contraceptive Agents, Female / blood*
  • Contraceptive Agents, Female / therapeutic use*
  • Drug Administration Schedule
  • Drug Combinations
  • Ethinyl Estradiol / blood*
  • Ethinyl Estradiol / therapeutic use*
  • Female
  • Humans
  • Levonorgestrel / analogs & derivatives*
  • Levonorgestrel / blood
  • Levonorgestrel / pharmacology*
  • Levonorgestrel / therapeutic use*
  • Middle Aged
  • Norgestrel / analogs & derivatives*
  • Norgestrel / blood*
  • Norgestrel / therapeutic use*
  • Oximes
  • Time Factors

Substances

  • Contraceptive Agents, Female
  • Drug Combinations
  • Oximes
  • Norgestrel
  • Ethinyl Estradiol
  • Levonorgestrel
  • norgestimate
  • norelgestromin