Efficacy and safety of a transdermal contraceptive system.
OBJECTIVE
To evaluate the efficacy, cycle control, compliance, and safety of a transdermal contraceptive system that delivers norelgestromin 150 microg and ethinyl estradiol 20 microg daily.


METHODS
In this open-label, 73-center study, 1672 healthy, ovulatory, sexually active women received ORTHO EVRA/EVRA for six (n = 1171) or 13 cycles (n = 501). The treatment regimen for each cycle was three consecutive 7-day patches (21 days) followed by 1 patch-free week.


RESULTS
The overall and method-failure probabilities of pregnancy through 13 cycles were 0.7% and 0.4%, respectively. The incidence of breakthrough bleeding was low throughout the study. Perfect compliance (21 consecutive days of dosing, followed by a 7-day drug-free interval; no patch could be worn for more than 7 days) was achieved in 90% of subject cycles; only 1.9% of patches detached completely. Adverse events were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting. The most common adverse events resulting in discontinuation were application site reactions (1.9%), nausea (1.8%), emotional lability (1.5%), headache (1.1%), and breast discomfort (1.0%).


CONCLUSIONS
The transdermal contraceptive patch provides effective contraception and cycle control, and is well tolerated. The weekly change schedule for the contraceptive patch is associated with excellent compliance and wearability characteristics.
Smallwood
G H
GH
R.W. Johnson Phamaceutical Research Institute, Raritan, NJ, USA.
Meador
M L
ML
Lenihan
J P
JP
Shangold
G A
GA
Fisher
A C
AC
Creasy
G W
GW
D000279:Administration, Cutaneous; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D011247:Pregnancy
D003271:Contraceptive Agents, Female; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; C449219:norelgestromin