Comparison of bleeding/spotting profiles between an extended regimen and a cyclic regimen of transdermal norelgestromin/ethinyl estradiol during the first 56 days of treatment

Abstract

Introduction: A subanalysis of a clinical trial comparing an extended regimen with a cyclic regimen of transdermal norelgestromin (NGMN)/ethinyl estradiol (EE) was conducted to assess differences in bleeding/spotting profiles between regimens during the first 56 days (two cycles) of treatment. Materials and Methods: Healthy regularly menstruating women (N=239) were randomized 2:1 to receive an extended regimen (n=158, weekly patch applications for 12 weeks/one patch-free week/three weekly applications) or a cyclic regimen (n=81, four consecutive cycles of three weekly patch applications/one patch-free week) of NGMN/EE. Subjects recorded bleeding data daily. Results for the intent-to-treat population are presented. Results: During the first 56 days of treatment, women receiving the extended regimen versus those receiving the cyclic regimen, respectively, had significantly fewer median bleeding days (1 vs. 9; p<.001), bleeding episodes (0.5 vs. 2; p<.001), bleeding/spotting days (6 vs. 10; p=.009) and bleeding/spotting episodes (1 vs. 2; p<.001) and a higher incidence of amenorrhea (28% vs. 1%; p<.001). Median time to first bleeding with the extended regimen versus the cyclic regimen was 54 versus 25 days, respectively (p<.001). Discussion: This is one of the largest trials to date to assess an extended regimen of a hormonal contraceptive approved for cyclic use. During the first 56 days of treatment, the extended regimen had significantly fewer median bleeding/spotting days compared with the cyclic regimen and effectively delayed menses. Conclusion: Extended-regimen transdermal NGMN/EE delays menses and reduces bleeding during the first 56 days of treatment compared with the cyclic regimen, a profile that may be preferred by women who seek flexibility with their contraceptive method.