Contraceptive efficacy and cycle control with the Ortho Evra™/Evra™ transdermal system: the analysis of pooled data

TLDR

The study pooled data from three pivotal contraceptive patch trials to evaluate efficacy and cycle control. The authors conducted three multicenter, open‑label studies enrolling 3,319 women who applied a 7‑day patch for 21 days followed by a week off, across up to 13 cycles. Across 13 cycles, contraceptive failure was 0.8% and method failure 0.6%, with low breakthrough bleeding that declined over time; efficacy was high and similar across age, race, and weight groups, though women ≥90 kg had a slightly higher pregnancy risk, and performance matched that of established oral contraceptives.

Abstract

Objective: To present efficacy and cycle control data pooled from three pivotal studies of the contraceptive patch (Ortho Evra™/Evra™).Design: Three multicenter, open-label, contraceptive studies that included up to 13 treatment cycles.Setting: 183 centers.Patient(s): 3,319 women.Intervention(s): Three consecutive 7-day patches (21 days) with 1 patch-free week per cycle.Main Outcome Measure(s): Contraceptive efficacy and cycle control.Result(s): 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 ≥90 kg (≥198 lb) may have increased risk of pregnancy. The incidence of breakthrough bleeding was low and decreased over time.Conclusion(s): 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 ≥90 kg (≥198 lb), contraceptive failures may be increased. Efficacy and cycle control have been shown to be comparable to an established oral contraceptive.