Integrated summary of ORTHO EVRA™/EVRA™ contraceptive patch adhesion in varied climates and conditions.

Abstract

Objective: To determine the adhesive reliability of a contraceptive patch, which delivers norelgestromin 150 μg daily and ethinyl estradiol 20 μg daily to systemic circulation. Design: Healthy women (n = 3480) were exposed to a contraceptive patch for 4 to 13 cycles. Each cycle consisted of 3 consecutive 7-day patches (21 days) followed by a patch-free week. Thirty women used the contraceptive patch under various conditions of heat, humidity, and exercise. They wore the patch for 7 days under 1 of 6 conditions (normal activity, sauna, whirlpool, treadmill, cool water immersion, or a combination of activities); treatment periods were separated by a 4-week washout phase. Patches were worn on any of 4 anatomic sites (buttocks, abdomen, upper outer arm, or upper torso) in the contraceptive studies and only on the abdomen in the 4-cycle study and exercise study. Materials/Methods: In all studies, patch replacement information was used as a surrogate marker of patch adhesion. In the exercise study, study personnel evaluated patch adhesion at each treatment period. In all studies, the percentage of patches replaced for the reason of “fell off” was summarized as patches that completely detached due to lack of adhesion. The percentage of patches replaced because of partial detachment was also summarized. Results: In the contraceptive studies, 4.7% of patches were replaced because they either fell off (1.8%) or were partly detached (2.9%). Patch replacement rates in centers from a warm, humid climate were 1.7% and 2.6%. Only 1 of 87 (1.1%) patches completely detached under conditions of heat, humidity, and exercise. Patch replacement rates for complete and partial detachment. ∗Contraceptive StudiesUS Centers With Warm, Humid Climate∗Includes 11 centers in Florida, Georgia, and Louisiana (subset of contraceptive studies).4-Cycle StudyExercise StudyTotal no. of patches worn705524877166387Replacement for complete detachment1297 (1.8%)85 (1.7%)6 (0.4%)1 (1.1%)Replacement for partial detachment2050 (2.9%)128 (2.6%)12 (0.7%)0∗ Includes 11 centers in Florida, Georgia, and Louisiana (subset of contraceptive studies). Open table in a new tab Conclusions: The adhesive reliability of a new contraceptive patch is excellent and is not affected by heat, humidity, swimming, bathing, exercise, or skin moisture, regardless of whether the source of moisture is external (e.g., sauna, whirlpool) or internal (e.g., perspiration). Supported By: The R.W. Johnson Pharmaceutical Research Institute.