title: Contraceptive efficacy and tolerability with a novel combined contraceptive vaginal ring, NuvaRing.
abstract: NuvaRing is a novel combined contraceptive vaginal ring that releases 15 microg of ethinylestradiol and 120 microgram etonogestrel per day. Each ring is used for one cycle, comprising 3 weeks continuous use of the ring followed by a 1-week ring-free period. The contraceptive efficacy and safety of NuvaRing have been studied in a 1-year, open study conducted in 1,145 women. Six pregnancies occurred in 12,109 cycles of exposure, giving a Pearl index of 0.65 (95% confidence interval (CI), 0.24-1.41). However, three of the six women violated the NuvaRing regimen in the cycle of conception. Compliance with the prescribed regimen was high, with criteria being fulfilled in 90.8% of cycles. During the 1 year of the study, 41% of the women did not experience any adverse events. The most frequently reported treatment-related adverse events were headache (6.6%), leukorrhea (5.3%) and vaginitis (5.0%). There was a low incidence of estrogen-related adverse events such as nausea (2.8%) and breast tenderness (1.9%). A total of 173 women (15.1%) discontinued due to an adverse event, with device-related events (comprising ring expulsion, foreign body sensation or coital problems) being the most commonly reported (2.6%). There were no clinically relevant changes in blood biochemistry, hematology, blood pressure, heart rate, body weight, physical examination or cervical cytology. In conclusion, NuvaRing is an effective contraceptive that is well tolerated, has a good safety profile and is not associated with unwanted effects on the cervix.
authors.affiliation: Department of Obstetrics and Gynecology, Atrium Medical Center, Heerlen, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Roumen
mesh_terms: D003257:Consumer Product Safety; D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000627:therapeutic use*; D003274:Contraceptive Devices, Female; D017135:Desogestrel; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D011247:Pregnancy; D018873:Pregnancy Rate; D014753:Vinyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D003271:Contraceptive Agents, Female; D014753:Vinyl Compounds; C044815:etonogestrel; D004997:Ethinyl Estradiol; D017135:Desogestrel