Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data.
OBJECTIVE
To present efficacy and cycle control data pooled from three pivotal studies of the contraceptive patch (Ortho Evra/Evra).


METHODS
Three multicenter, open-label, contraceptive studies that included up to 13 treatment cycles.


METHODS
183 centers.


METHODS
3,319 women.


METHODS
Three consecutive 7-day patches (21 days) with 1 patch-free week per cycle.


METHODS
Contraceptive efficacy and cycle control.


RESULTS
Overall and method failure life-table estimates of contraceptive failure through 13 cycles were 0.8% (95% CI, 0.3%-1.3%) and 0.6% (95% CI, 0.2%-0.9%), respectively. Corresponding Pearl indices were 0.88 (95% CI, 0.44-1.33) and 0.7 (95% CI, 0.31-1.10). Contraceptive failure among women with a body weight < 90 kg (<198 lb) was low and uniformly distributed across the weight range. A subgroup of women with body weight > or = 90 kg (> or = 198 lb) may have increased risk of pregnancy. The incidence of breakthrough bleeding was low and decreased over time.


CONCLUSIONS
In contraceptive patch users, the overall annual probability of pregnancy was 0.8% and the method failure probability was 0.6%. The efficacy of the patch was high and similar across age and racial groups. Among women < 90 kg (<198 lb), contraceptive failure was low and uniformly distributed across the range of body weights. In women > or = 90 kg (> or = 198 lb), contraceptive failures may be increased. Efficacy and cycle control have been shown to be comparable to an established oral contraceptive.
Zieman
Miriam
M
Emory University School of Medicine, Atlanta, Georgia, USA.
Guillebaud
John
J
Weisberg
Edith
E
Shangold
Gary A
GA
Fisher
Alan C
AC
Creasy
George W
GW
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001835:Body Weight; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000592:standards; D004338:Drug Combinations; D016503:Drug Delivery Systems; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000592:standards; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D011247:Pregnancy; D016016:Proportional Hazards Models
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D005003:Ethisterone; C449219:norelgestromin