A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra).
OBJECTIVE
To review the safety and tolerability of the contraceptive patch (Ortho Evra/Evra) versus a standard oral contraceptive (Triphasil) and to present the pooled safety and tolerability of the patch across three pivotal studies.


METHODS
Three open-label, contraceptive studies of up to 13 treatment cycles.


METHODS
183 centers.


METHODS
Comparative study (812 patch, 605 oral contraceptive); pooled analysis (3,330 patch).


METHODS
The patch regimen was three consecutive 7-day patches (21 days) followed by 1 patch-free week per cycle; the oral contraceptive was dosed according to the U.S. physician package insert.


METHODS
Adverse events, laboratory tests, vital signs, and body weight.


RESULTS
The incidence of most events was similar between the patch and oral contraceptive groups, with the exception of a higher incidence of application site reactions, breast discomfort (cycles 1 and 2 only), and dysmenorrhea in the patch group. Pooled analysis demonstrated that most application site reactions (92%) and breast symptoms (86%) were mild or moderate in severity, and <2% of participants discontinued the patch because of either event. Only 7 (0.2%) participants experienced a serious adverse event classified as possibly, probably, or likely related to the patch. The mean change in body weight from baseline to the end of treatment was an increase of 0.3 kg.


CONCLUSIONS
Overall, the contraceptive patch is well tolerated and has a side effect profile similar to an established oral contraceptive.
Sibai
Baha M
BM
University of Cincinnati, College of Medicine, Cincinnati, Ohio, USA.
Odlind
Viveca
V
Meador
Mary L
ML
Shangold
Gary A
GA
Fisher
Alan C
AC
Creasy
George W
GW
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects* / Q000592:standards; D004338:Drug Combinations; D016503:Drug Delivery Systems; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D011247:Pregnancy
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; D005003:Ethisterone; C449219:norelgestromin