1. 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
- Author
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Crosignani, Pg, Nappi, C, Ronsini, S, Bruni, V, Marelli, S, Sonnino, D, Affronti, G, Benagiano, G, Benedetto, C, Bolis, G, Cianci, A, Fedele, L, Garsia, S, Genazzani, Andrea, Gherzi, R, Masellis, G, Melis, G, Moscarini, M, Piccione, E, Quartararo, P, Ragni, N, Scagliola, P, Schönauer, S, Sismondi, P, Venturini, Pl, Volpe, A, Italian EVRA Contrast Study Group, Zullo F., Crosignani, Pg, Nappi, Carmine, Ronsini, S, Bruni, V, Marelli, S, Sonnino, D., Crosignani, Pier Giorgio, Ronsini, Salvatore, Bruni, Vincenzina, Marelli, Silvia, Sonnino, Davide, Affronti, G., Benagiano, G., Benedetto, C., Bolis, G., Cianci, A., Fedele, L., Garsia, A., Genazzani, A. R., Gherzi, R., Masellis, G., Melis, G., Moscarini, M., Piccione, E., Quartararo, P., Ragni, N., Scagliola, P., Schönauer, S., Sismondi, P., Venturini, P. L., Volpe, A., and Zullo, F.
- Subjects
Ethinyl Estradiol-Norgestrel Combination ,systolic blood pressure ,drug safety ,personal experience ,Birth control ,Oxime ,Pregnancy ,Obstetrics and Gynaecology ,Oximes ,Medicine ,Norelgestromin ,norelgestromin ,birth control ,media_common ,ethinylestradiol plus norelgestromin ,drug derivative ,ethinylestradiol plus norgestrel ,norgestrel ,oral contraceptive agent ,oxime ,adult ,article ,barrier contraception ,breast tension ,clinical trial ,diastolic blood pressure ,drug efficacy ,drug induced headache ,drug tolerability ,female ,hormonal contraception ,human ,Italy ,local skin reaction ,major clinical study ,mastalgia ,multicenter study ,nausea ,oral contraception ,patient compliance ,patient satisfaction ,pruritus ,pulse rate ,quality of life ,spotting ,vagina contraception ,adolescent ,intradermal drug administration ,middle aged ,pregnancy ,statistics ,treatment outcome ,Administration, Cutaneous ,Adolescent ,Adult ,Contraceptives, Oral, Combined ,Female ,Humans ,Middle Aged ,Norgestrel ,Patient Compliance ,Patient Satisfaction ,Quality of Life ,Treatment Outcome ,Young Adult ,Medicine(all) ,Combined ,Obstetrics ,lcsh:Public aspects of medicine ,Obstetrics and Gynecology ,Contraceptives ,General Medicine ,Drug Combinations ,Family planning ,Pill ,Administration ,Developed country ,Contraceptive patch ,Human ,medicine.drug ,Research Article ,Oral ,Administration, Cutaneou ,medicine.medical_specialty ,media_common.quotation_subject ,lcsh:Gynecology and obstetrics ,Adverse effect ,lcsh:RG1-991 ,Gynecology ,business.industry ,lcsh:RA1-1270 ,Cutaneous ,Reproductive Medicine ,Hormonal contraception ,Settore MED/40 - Ginecologia e Ostetricia ,business - Abstract
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.
- Published
- 2009