Efficacy, Cycle Control, and User Acceptability of a Novel Combined Contraceptive Vaginal Ring

Abstract

In Brief OBJECTIVE To assess the contraceptive efficacy, cycle control, tolerability, and user acceptability of a novel combined contraceptive vaginal ring for up to 13 cycles. METHODS Healthy women requesting contraception were enrolled in this 1-year multicenter study. Each ring released 120 μg of etonogestrel and 15 μg of ethinylestradiol daily, and was used for 3 weeks followed by a 1-week ring-free period. RESULTS A total of 2322 women started treatment and so formed the intent-to-treat population. Subjects were followed for 23,298 cycles, equivalent to 1786 woman-years. Compliance was good with 85.6% of cycles in full compliance with specified criteria. In the intent-to-treat population, 21 pregnancies occurred, giving a Pearl Index of 1.18 (95% confidence interval 0.73, 1.80). Eleven of the pregnancies were attributable to noncompliance; the Pearl Index for the per-protocol population was 0.77 (95% confidence interval 0.37, 1.40). The mean incidence of withdrawal bleeding was 98.5% in all cycles. Irregular bleeding occurred in 5.5% of all cycles, and in most women, early or late withdrawal bleeding was restricted to spotting. The ring was well tolerated with a low incidence of adverse events; only 2.5% of all discontinuations were device related. The ring was easy to insert and remove and did not interfere with intercourse. Eighty-five percent of women were satisfied with the ring, and 90% would recommend its use to others. CONCLUSION The ring is an effective contraceptive with excellent cycle control that is convenient, well tolerated, and highly acceptable to users. This novel combined contraceptive vaginal ring is effective, has excellent cycle control, and is well tolerated and convenient to use.