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Obstetrics & Gynecology 2005;105:1389-1396
© 2005 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Extended Use of Transdermal Norelgestromin/Ethinyl Estradiol: A Randomized Trial

Felicia H. Stewart, MD, Andrew M. Kaunitz, MD, Katherine D. LaGuardia, MD, MPH, Debra L. Karvois, Alan C. Fisher, DrPH, Andrew J. Friedman, MD for the ORTHO EVRA Extended Regimen Study Group*

From the University of California San Francisco, Center for Reproductive Health Research & Policy, San Francisco, California; University of Florida Health Science Center, Jacksonville, Florida; Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey; and Johnson & Johnson Pharmaceutical Research and Development, Raritan, New Jersey.

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.

LEVEL OF EVIDENCE: I




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W. A. Fisher and A. Black
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Can. Med. Assoc. J., March 27, 2007; 176(7): 953 - 961.
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Extended Use of the Contraceptive Patch
Journal Watch Women's Health, August 2, 2005; 2005(802): 6 - 6.
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