Integrated summary of Ortho Evra/Evra contraceptive patch adhesion in varied climates and conditions.
OBJECTIVE
To assess the adhesive reliability of the contraceptive patch (Ortho Evra/Evra).


METHODS
Pooled data of 3,319 women from three contraceptive studies of up to 13 treatment cycles; a subset of 325 women of the pooled data from warm and humid climates; and 30 women from a three-period, crossover exercise study.


METHODS
184 centers.


METHODS
3,349 healthy women.


METHODS
In the contraceptive studies, each treatment cycle consisted of three consecutive 7-day patches (21 days) followed by one patch-free week. During each treatment period in the exercise study, women wore the patch for 7 days and participated in one of six activities (normal activity, excluding bathing; sauna; whirlpool; treadmill; cool-water immersion; or a combination of activities) each day at a supervised health center.


METHODS
Patch adhesion.


RESULTS
In the contraceptive studies, 4.7% of patches were replaced because they fell off (1.8% [1,297 of 70,552 patches]) or became partly detached (2.9% [2,050 of 70,552 patches]); patch replacement rates in centers from a warm, humid climate were 1.7% (85 of 4,877 patches) and 2.6% (128 of 4,877 patches), respectively. Only one of 87 patches (1.1%) completely detached in the exercise study.


CONCLUSIONS
The reliability of adhesion of the contraceptive patch is excellent and consistent across all studies; only 1.8% and 2.9% of patches required replacement due to complete or partial detachment, respectively. Heat, humidity, and exercise do not affect adhesion.
Zacur
Howard A
HA
Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Hedon
Bernard
B
Mansour
Diana
D
Shangold
Gary A
GA
Fisher
Alan C
AC
Creasy
George W
GW
D000269:Adhesives; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D002980:Climate; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004338:Drug Combinations; D016503:Drug Delivery Systems; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005003:Ethisterone / Q000031:analogs & derivatives; D015444:Exercise; D005260:Female; D006358:Hot Temperature / Q000009:adverse effects; D006801:Humans; D006813:Humidity / Q000009:adverse effects; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes
D000269:Adhesives; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D005003:Ethisterone; C449219:norelgestromin