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1.
Contraception ; 74(6): 451-7, 2006 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-17157101

RESUMO

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.


Assuntos
Androstenos/administração & dosagem , Etinilestradiol/administração & dosagem , Dispositivos Intrauterinos , Adolescente , Adulto , Androstenos/efeitos adversos , Anticoncepção , Anticoncepcionais/administração & dosagem , Anticoncepcionais/efeitos adversos , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Combinados/efeitos adversos , Desogestrel/administração & dosagem , Desogestrel/efeitos adversos , Desogestrel/análogos & derivados , Combinação de Medicamentos , Etinilestradiol/efeitos adversos , Feminino , Humanos , Dispositivos Intrauterinos/efeitos adversos , Cooperação do Paciente , Satisfação do Paciente , Gravidez , Congêneres da Progesterona/administração & dosagem , Congêneres da Progesterona/efeitos adversos , Resultado do Tratamento
2.
Eur J Obstet Gynecol Reprod Biol ; 121(2): 202-10, 2005 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-16054963

RESUMO

OBJECTIVE: To investigate contraceptive efficacy, compliance and user's satisfaction with transdermal versus oral contraception (OC). STUDY DESIGN: Randomized, open-label, parallel-group trial conducted at 65 centers in Europe and South Africa. One thousand four hundred and eighty-nine women received a contraceptive patch (n = 846) or an OC (n = 643) for 6 or 13 cycles. RESULTS: Overall/method-failure Pearl Indices were 0.88/0.66 with the patch and 0.56/0.28 with the OC (p = n.s.). Compliance was higher at all age groups with the patch compared to the OC. Significantly more users were very satisfied with the contraceptive patch than with the OC. The percentage of patch users being very satisfied increased with age whereas it did not in the OC group. Likewise, improvements of premenstrual symptoms as well as emotional and physical well-being increased with age in the patch-group in contrast to the OC group. Ratings of satisfaction with the study medication correlated weakly with emotional (r = 0.33) and physical well-being (r = 0.39) as well as premenstrual symptoms (r = 0.30; p < 0.001). CONCLUSION: Contraceptive efficacy of the patch is comparable to OC, but compliance is consistently better at all age groups. Higher satisfaction with the patch at increasing age may be attributed to improvements in emotional and physical well-being as well as reduction of premenstrual symptoms.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Orais Hormonais/administração & dosagem , Cooperação do Paciente , Satisfação do Paciente , Administração Cutânea , Administração Oral , Adulto , Esquema de Medicação , Feminino , Humanos , Resultado do Tratamento
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