Satisfaction and compliance in hormonal contraception: The result of a multicentre clinical study on women's experience with the ethinylestradiol/norelgestromin contraceptive patch in Italy

被引:7
作者
Crosignani P.G. [1 ]
Nappi C. [2 ,19 ]
Ronsini S. [3 ,23 ]
Bruni V. [4 ,10 ]
Marelli S. [4 ]
Sonnino D. [5 ]
Affronti G. [6 ]
Benagiano G. [7 ]
Benedetto C. [8 ]
Bolis G. [9 ]
Cianci A. [11 ]
Fedele L. [12 ]
Garsia A. [13 ]
Genazzani A.R. [14 ]
Gherzi R. [15 ]
Masellis G. [16 ]
Melis G. [17 ]
Moscarini M. [18 ]
Piccione E. [20 ]
Quartararo P. [21 ]
Ragni N. [22 ]
Scagliola P. [24 ]
Schönauer S. [25 ]
Sismondi P. [26 ]
Venturini P.L. [27 ]
Volpe A. [28 ]
Zullo F. [29 ]
机构
[1] II Institute of Obstetrics and Gynaecology, University of Milan, Milan
[2] Department of Obstetric-Gynaecological, Urological Sciences and Reproduction Medicine, University of Naples, Naples
[3] Department of Maternal and Children's Sciences, ASL SA 3 San Luca Hospital, Vallo della Lucania, SA
[4] Department of Gynaecology, Perinatology and Human Reproduction, University of Florence, Florence
[5] Medical Affairs Department, Janssen-Cilag SpA, Cologno Monzese, MI
[6] Azienda Ospedaliera di Perugia, Perugia
[7] Università degli Studi di Roma La Sapienza, Roma
[8] Azienda Ospedaliera O.I.R.M.S. Anna, Torino
[9] Azienda Ospedaliera S. Paolo, Milano
[10] Policnico Careggi, Università degli Studi di Firenze, Firenze
[11] Azienda Ospedaliera Universitaria V. Emanuele-Ferrarotto-S. Bambino, Catania
[12] Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milano
[13] Azienda Ospedaliera Niguarda Cà Granda, Milano
[14] Università degli Studi di Pisa, Pisa
[15] Azienda Ospedaliera Maggiore della Carità, Novara
[16] Ospedale Civile Ramazzini, Carpi, MO
[17] Ospedale S. Giovanni di Dio, Cagliari
[18] Azienda Ospedaliera S. Andrea, Roma
[19] Università degli Studi Federico II, Napoli
[20] Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma
[21] Policlinico Paolo Giaccone, Palermo
[22] Università degli Studi di Genova, Genova
[23] Ospedale San Luca, Vallo della Lucania, SA
[24] Spedali Civili di Brescia, Brescia
[25] Azienda Ospedaliera Ospedale Policlinico Consorziale, Bari
[26] Azienda Sanitaria Ospedaliera Ordine Mauriziano, Torino
[27] Istituto Giannini Gaslini, Genova
[28] Azienda Ospedaliera di Modena, Modena
[29] Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro
关键词
Oral Contraceptive; Contraceptive Method; Unintended Pregnancy; Ethinylestradiol; Bioelectrical Impedance Analysis;
D O I
10.1186/1472-6874-9-18
中图分类号
学科分类号
摘要
Background: For many women finding the right contraceptive method can be challenging and consistent and correct use over a lifetime is difficult. Even remembering to take a birth control pill every day can be a challenge. The primary objective of this study was to evaluate women's experience with a weekly ethinylestradiol/norelgestromin contraceptive patch (EE/NGMN patch), given new technologies recently developed in hormonal contraception to increase women's options in avoiding daily dosing. Methods: In 24 Italian sites, 207 women received the EE/NGMN patch for up to 6 cycles. At study end, overall satisfaction and preference, as well as compliance, efficacy and safety, were evaluated. Results: 175 women (84.5%) completed the study. The overall satisfaction rate was 88%; convenience and once-a-week frequency of the patch were especially appreciated. At baseline, 82 women (39.4%) were using a contraceptive method, mainly oral contraceptives and barrier methods, but only 45.1% were very satisfied/satisfied; after 6 months with the patch, 86.3% of this subset was very satisfied/satisfied. Considering the method used in the 3 months before the study entry, 78.1% strongly preferred/preferred the patch, for convenience (53.9%), ease of use/ simplicity (28.9%), fewer (9.2%) and less severe (2.6%) side effects. Compliance was very high: 1034/1110 cycles (93.2%) were completed with perfect compliance and the mean subject's compliance score was 90%. One on-therapy pregnancy occurred. The patch was safe and well tolerated: adverse events frequency was low, with predominantly single reports of each event. Most of them started and subsided during cycle 1. Conclusion: This study demonstrated that the EE/NGMN patch is associated with high satisfaction levels and excellent compliance. At study end, the majority of women indicated that they would continue using the patch. © 2009 Crosignani et al; licensee BioMed Central Ltd.
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共 37 条
[1]  
Petitti D.B., Combination estrogen-progestin oral contraceptives, NEJM, 349, pp. 1443-1450, (2003)
[2]  
Kubba A., Guillebaud J., Anderson R.A., MacGregor E.A., Contraception, The Lancet, 356, pp. 1913-1919, (2000)
[3]  
Frost J.J., Darroch J.E., Remez L., Improving contraceptive use in the United States, Brief, (2008)
[4]  
Rosenberg M.J., Waugh M.S., Burnhill M.S., Compliance, counseling and satisfaction with oral contraceptives: A prospective evaluation, Fam Plann Perspect, 30, pp. 89-92, (1998)
[5]  
Rosenberg M.J., Waugh M.S., Meehan T.E., Use and misuse of oral contraceptives: Risk indicators for poor pill taking and discontinuation, Contraception, 51, pp. 283-288, (1995)
[6]  
Suwanmalee O., Taneepanichskul S., A clinical study of transdermal contraceptive patch in Thai women, J Med Assoc Thai, 89, (2006)
[7]  
Prausnitz M.R., Mitragotri S., Langer R., Current status and future potential of transdermal drug delivery, Nature Rev Drug Discov, 3, 2, pp. 115-124, (2004)
[8]  
Graziottin A., A review of transdermal hormonal contraception. Focus on the ethinylestradiol/norelgestromin contraceptive patch, Treat Endocrinol, 5, 6, pp. 359-365, (2006)
[9]  
Burkman R., Transdermal hormonal contraception: Benefits and risks, Am J Obstet Gynecol, 197, (2007)
[10]  
Abrams L.S., Skee D.M., Natarajan J., Wong F.A., Pharmacokinetic overview of Ortho Evra™/Evra™, Fertil Steril, 77, 2 SUPPL. 2, (2002)