Purpose: This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 μg 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 μg of EE and 3 mg drospirenone. User acceptability of both methods was high. © 2006 Elsevier Inc. All rights reserved.
Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 μg of ethinyl estradiol and 3 mg of drospirenone / Hans Joachim, Ahrendt; Israel, Nisand; Bastianelli, Carlo; Maria Angeles, Gomez; Kristina Gemzell, Danielsson; Wolfgang, Urdl; Birgit, Karskov; Luc, Oeyen; Johannes, Bitzer; Geert, Page; Ian, Milsom. - In: CONTRACEPTION. - ISSN 0010-7824. - STAMPA. - 74:6(2006), pp. 451-457. [10.1016/j.contraception.2006.07.004]
Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 μg of ethinyl estradiol and 3 mg of drospirenone
BASTIANELLI, Carlo;
2006
Abstract
Purpose: This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 μg 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 μg of EE and 3 mg drospirenone. User acceptability of both methods was high. © 2006 Elsevier Inc. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.