PURPOSE: This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 microg of ethinyl estradiol (EE) and 3 mg of drospirenone. METHOD: In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) withNuvaRing or COC. RESULTS: One in-treatment pregnancy occurred with NuvaRing (Pearl Index=0.25) (95% confidence interval [CI]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% CI: 0.269, 2.530). For both groups, compliance (89.2% NuvaRing, 85.5% COC) and satisfaction (84% NuvaRing; 87% COC) were high; the vast majority of women found NuvaRing easy to insert (96%) and remove (97%). Tolerability was similar; the most frequent adverse events with NuvaRing were related to ring use, whereas estrogen-related events were more common with the COC. CONCLUSION: NuvaRing has comparable efficacy and tolerability to a COC containing 30 microg of EE and 3 mg drospirenone. User acceptability of both methods was high.
RCT Entities:
PURPOSE: This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 microg of ethinyl estradiol (EE) and 3 mg of drospirenone. METHOD: In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) with NuvaRing or COC. RESULTS: One in-treatment pregnancy occurred with NuvaRing (Pearl Index=0.25) (95% confidence interval [CI]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% CI: 0.269, 2.530). For both groups, compliance (89.2% NuvaRing, 85.5% COC) and satisfaction (84% NuvaRing; 87% COC) were high; the vast majority of women found NuvaRing easy to insert (96%) and remove (97%). Tolerability was similar; the most frequent adverse events with NuvaRing were related to ring use, whereas estrogen-related events were more common with the COC. CONCLUSION: NuvaRing has comparable efficacy and tolerability to a COC containing 30 microg of EE and 3 mg drospirenone. User acceptability of both methods was high.
Authors: Lauren B Zapata; Maria W Steenland; Dalia Brahmi; Polly A Marchbanks; Kathryn M Curtis Journal: Contraception Date: 2012-10-22 Impact factor: 3.375
Authors: Suchitra N Pandit; Anahita R Chauhan; Manjula Anagani; Sanjeeva Reddy; Ashish Birla; Subrat K Ray Journal: J Obstet Gynaecol India Date: 2014-05-15
Authors: Ruth B Merkatz; Marlena Plagianos; Elena Hoskin; Michael Cooney; Paul C Hewett; Barbara S Mensch Journal: Contraception Date: 2014-06-02 Impact factor: 3.375