Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol.
A novel contraceptive vaginal ring releasing etonogestrel 120 microg and ethinyl oestradiol 15 microg daily over a period of 3 weeks was tested. Each ring was used for one cycle, comprising 3 weeks of ring use followed by a 1 week ring-free period. This 1 year, multicentre study assessed the contraceptive efficacy, cycle control, tolerability and acceptability of the contraceptive. Altogether, 1145 women were exposed to the vaginal ring for 12,109 cycles (928 woman-years). Six pregnancies occurred during treatment, giving a Pearl Index of 0.65 (95% confidence interval 0.24--1.41). Cycle control was very good, since irregular bleeding was rare (2.6--6.4% of evaluable cycles) and withdrawal bleeding (mean duration 4.7--5.3 days) occurred in 97.9--99.4% of evaluable cycles. Compliance to the prescribed regimen was high with criteria being fulfilled in 90.8% of cycles. The ring was well tolerated. The majority of women considered this new contraceptive method easy to use, and it offers an effective, convenient, well-accepted and novel method for hormonal contraception.
Atrium Medisch Centrum, Department of Obstetrics and Gynecology, Heerlen, The Netherlands. roumenfj@knmg.nl
F J
FJ
Roumen
D
D
Apter
T M
TM
Mulders
T O
TO
Dieben
D002584:Cervix Uteri / Q000166:cytology; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D003274:Contraceptive Devices, Female / Q000009:adverse effects / Q000592:standards*; D017135:Desogestrel; D045166:Estradiol Congeners / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D010349:Patient Compliance; D014753:Vinyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology
D003271:Contraceptive Agents, Female; D045166:Estradiol Congeners; D014753:Vinyl Compounds; C044815:etonogestrel; D004997:Ethinyl Estradiol; D017135:Desogestrel