Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial

Obstet Gynecol. 2005 Jun;105(6):1389-96. doi: 10.1097/01.AOG.0000160430.61799.f6.

Abstract

Objective: To compare bleeding profiles and satisfaction among women using a norelgestromin/ethinyl estradiol (E2) transdermal contraceptive patch in an extended regimen to those among women using a traditional 28-day patch regimen.

Methods: Healthy, regularly menstruating women (N = 239) were randomly assigned (2:1 ratio) to receive the norelgestromin/ethinyl E2 transdermal patch in an extended regimen (weekly application for 12 consecutive weeks, 1 patch-free week, and 3 more consecutive weekly applications, n = 158) or a cyclic regimen (4 consecutive cycles of 3 weekly applications and 1 patch-free week, n = 81). Subjects recorded bleeding data daily and completed satisfaction questionnaires. Subjects and investigators provided overall assessments of the regimens.

Results: Extended use of the norelgestromin/ethinyl E2 transdermal patch resulted in fewer median bleeding days (6 compared with 14, P < .001), bleeding episodes (1 compared with 3, P < .001), and bleeding or spotting episodes (2 compared with 3, P < .001) compared with cyclic use during days 1-84; median numbers of bleeding or spotting days were similar between regimens (14 compared with 16, P = .407) during this time. Extended use delayed median time to first bleeding to 54 days compared with 25 days with cyclic (P < .001). Subjects were highly satisfied with both regimens. Although not statistically significant, slightly more adverse events were reported with the extended than with the 28-day regimen.

Conclusion: Compared with cyclic use, extended use of the norelgestromin/ethinyl E2 transdermal patch delayed menses and resulted in fewer bleeding days. This regimen may represent a useful alternative for women who prefer fewer episodes of withdrawal bleeding.

Publication types

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

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Contraceptives, Oral, Combined / administration & dosage*
  • Drug Administration Schedule
  • Drug Combinations
  • Estrogens / administration & dosage*
  • Ethinyl Estradiol / administration & dosage*
  • Ethisterone / analogs & derivatives
  • Female
  • Humans
  • Menstruation / drug effects
  • Middle Aged
  • Norgestrel / analogs & derivatives
  • Oximes
  • Patient Satisfaction

Substances

  • Contraceptives, Oral, Combined
  • Drug Combinations
  • Estrogens
  • Oximes
  • Norgestrel
  • Ethinyl Estradiol
  • Ethisterone
  • norelgestromin