Women’s health and gender-based clinical trials on etoricoxib: methodological gender bias

Por favor, use este identificador para citar o enlazar este ítem: http://hdl.handle.net/10045/10943
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Campo DCValorIdioma
dc.contributorSalud Públicaen
dc.contributor.authorChilet Rosell, Elisa-
dc.contributor.authorRuiz-Cantero, María Teresa-
dc.contributor.authorHorga de la Parte, José Francisco-
dc.contributor.otherUniversidad de Alicante. Departamento de Enfermería Comunitaria, Medicina Preventiva y Salud Pública e Historia de la Cienciaen
dc.contributor.otherHospital General Universitario de Alicante. Unidad de Farmacología Clínicaen
dc.date.accessioned2009-06-12T07:25:32Z-
dc.date.available2009-06-12T07:25:32Z-
dc.date.created2009-
dc.date.issued2009-03-14-
dc.identifier.citationCHILET ROSELL, Elisa; RUIZ CANTERO, María Teresa; HORGA DE LA PARTE, José Francisco. "Women’s health and gender-based clinical trials on etoricoxib: methodological gender bias". Journal of Public Health. Advance Access published online on March 14, 2009. ISSN 1741-3842, pp. 1-12en
dc.identifier.issn1741-3842 (Print)-
dc.identifier.issn1741-3850 (Online)-
dc.identifier.urihttp://hdl.handle.net/10045/10943-
dc.description.abstractBackground The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. Methods The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). Results Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors.en
dc.description.sponsorshipHealth Research Fund of Carlos III Health Institute of the Spanish Ministry of Health and Consumption. Women’s Studies Center of the University of Alicante.en
dc.languageengen
dc.publisherOxford University Pressen
dc.rights© The Author 2009, Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserveden
dc.subjectClinical trialsen
dc.subjectEtoricoxiben
dc.subjectGender biasen
dc.subjectGender differencesen
dc.subjectSex differencesen
dc.subject.otherMedicina Preventiva y Salud Públicaen
dc.titleWomen’s health and gender-based clinical trials on etoricoxib: methodological gender biasen
dc.typeinfo:eu-repo/semantics/articleen
dc.peerreviewedsien
dc.identifier.doi10.1093/pubmed/fdp024-
dc.relation.publisherversionhttp://dx.doi.org/10.1093/pubmed/fdp024-
dc.rights.accessRightsinfo:eu-repo/semantics/restrictedAccess-
Aparece en las colecciones:INV - SP - Artículos de Revistas
Institucional - IUIEG - Publicaciones

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