Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial

This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing...

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Bibliographic Details
Published in:Contraception (Stoneham) 2005-03, Vol.71 (3), p.176-182
Main Authors: Oddsson, Kristjan, Leifels-Fischer, Beate, de Melo, Nilson Roberto, Wiel-Masson, Dominique, Benedetto, Chiara, Verhoeven, Carole H.J., Dieben, Thom O.M.
Format: Article
Language:English
Subjects:
Adult
Compliance
Contraception - methods
Contraceptive
Contraceptive Devices, Female - adverse effects
Contraceptive Devices, Female - standards
Contraceptives, Oral, Combined - administration & dosage
Contraceptives, Oral, Combined - adverse effects
Dose-Response Relationship, Drug
Efficacy
Europe
Female
Headache - etiology
Humans
Leukorrhea - etiology
NuvaRing
Pill
South Africa
Time Factors
Tolerability
Treatment Outcome
Vaginitis - etiology
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Summary:This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 μg of ethinylestradiol (EE) and 120 μg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 μg of levonorgestrel (LNG) and 30 μg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 μg of LNG and 30 μg of EE and does not require daily dosing.
ISSN:0010-7824
1879-0518
DOI:10.1016/j.contraception.2004.09.001