Efficacy, cycle control, and user acceptability of a novel combined contraceptive vaginal ring.
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 microg of etonogestrel and 15 microg 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.


CONCLUSIONS
The ring is an effective contraceptive with excellent cycle control that is convenient, well tolerated, and highly acceptable to users.
Dieben
Thom O M
TO
Clinical Development Department, Contraception, NV Organon, Oss, the Netherlands. thom.dieben@organon.com
Roumen
Frans J M E
FJ
Apter
Dan
D
D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000494:pharmacology; D003274:Contraceptive Devices, Female; D017135:Desogestrel; D004343:Drug Implants; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D012680:Sensitivity and Specificity; D014621:Vagina; D014753:Vinyl Compounds / Q000627:therapeutic use*
D003271:Contraceptive Agents, Female; D004343:Drug Implants; D014753:Vinyl Compounds; C044815:etonogestrel; D004997:Ethinyl Estradiol; D017135:Desogestrel