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


CONCLUSIONS
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.
Stewart
Felicia H
FH
University of California San Francisco, Center for Reproductive Health Research and Policy, San Francisco, California, USA.
Kaunitz
Andrew M
AM
Laguardia
Katherine D
KD
Karvois
Debra L
DL
Fisher
Alan C
AC
Friedman
Andrew J
AJ
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004967:Estrogens / Q000008:administration & dosage*; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008598:Menstruation / Q000187:drug effects; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D017060:Patient Satisfaction
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D004967:Estrogens; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D005003:Ethisterone; C449219:norelgestromin