Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin

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dc.contributor.authorGama, Carlos Romualdo Barbosa [UNESP]
dc.contributor.authorGama, Gustavo Falcão
dc.contributor.authorLasmar, Ricardo Basil
dc.contributor.authorFonseca, Rogerio Sergio
dc.contributor.authorGuimarães, Lucia Cunegatto
dc.contributor.authorDe Aquino, Sabrina
dc.contributor.authorGeller, Mauro
dc.contributor.authorRibeiro, Rachel Leite
dc.contributor.institutionFMT-UNIFESO
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionHospital Mário Pena
dc.contributor.institutionUFF
dc.contributor.institutionInstituto Fernandes Figueira
dc.contributor.institutionServiço de Ginecologia do HCTCO
dc.contributor.institutionCentro Universitário Serra Dos Órgãos
dc.contributor.institutionUNIFESO
dc.contributor.institutionInstituto de Pós-Gradução Médica Carlos Chagas
dc.contributor.institutionUniversidade Federal do Rio de Janeiro (UFRJ)
dc.contributor.institutionUniversidade do Estado do Rio de Janeiro (UERJ)
dc.date.accessioned2014-05-27T11:24:47Z
dc.date.available2014-05-27T11:24:47Z
dc.date.issued2010-09-01
dc.description.abstractWe report on the results of a double-blind, randomized, controlled clinical trial comparing two preparations of ethinylestradiol and cyproterone acetate in the treatment of women of reproductive age presenting menstrual irregularities of hyper-androgenic origin. After obtaining informed consent, subjects were randomized to a 4-month treatment period consisting of one daily dose of 0.035mg ethinylestradiol + 2mg cyproterone acetate. The treatment regimen cycle consisted of one pill, once daily for 21 days, followed by a 7-day pill-free period. We compared the efficacy of two presentations of the drug combination after each treatment cycle (Visits 2, 3, 4, and 5) in establishment and maintenance of menstrual regulation, intensity of menstrual flow, and dysmenorrhea, as well as a comparison of the two presentations in terms of Global Satisfaction and Drug Satisfaction assessments performed by the patients and the investigating physician. At each study visit, drug compliance and use of concomitant medications, as well as incidence, severity and duration of adverse events were recorded. A total of 86 subjects were randomized to treatment, with 43 subjects in each treatment group. At Visit 2 and each subsequent visit, all patients in both treatment groups reported an episode of withdrawal bleeding during the 7-day hormone-free period. We observed a statistically significant (p<0.0001) decrease in the incidence of dysmenorrhea at each study visit in relation to the pretreatment assessment. There was a significant reduction (p<0.0001) in the number of subjects reporting intermenstrual bleeding at each study visit in both treatment groups. Global Satisfaction scores by the patient and physician increased significantly at each successive study visit in both treatment groups. There were no clinically significant changes in vital signs, weight, and body mass index throughout the study period in either group. The number of subjects reporting adverse events at each visit did not vary between treatment groups. The combined oral contraceptive pill containing ethinylestradiol and cyproterone acetate was found to be both effective and safe in the menstrual irregularities of hyper-androgenic origin (amenorrhea, dysmenorrhea, and intermenstrual bleeding) assessed in this study. © Copyright Moreira Jr. Editora. Todos os direitos reservados.en
dc.description.affiliationFMT-UNIFESO
dc.description.affiliationUniversidade Estadual de São Paulo (UNESP)
dc.description.affiliationServiço de Ginecologia Oncológica Hospital Mário Pena
dc.description.affiliationUFF
dc.description.affiliationInstituto Fernandes Figueira
dc.description.affiliationServiço de Ginecologia Oncológica Hospital São José Serviço de Ginecologia do HCTCO
dc.description.affiliationUniversidade Estácio de Sa Pós-graduada em Gestão Hospitalar Centro Universitário Serra Dos Órgãos
dc.description.affiliationUNIFESO
dc.description.affiliationInstituto de Pós-Gradução Médica Carlos Chagas
dc.description.affiliationUFRJ
dc.description.affiliationCentro de Ciências da Saúde UNIFESO
dc.description.affiliationUERJ
dc.description.affiliationUnespUniversidade Estadual de São Paulo (UNESP)
dc.format.extent319-325
dc.identifierhttp://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4443
dc.identifier.citationRevista Brasileira de Medicina, v. 67, n. 9, p. 319-325, 2010.
dc.identifier.issn0034-7264
dc.identifier.scopus2-s2.0-77958060948
dc.identifier.urihttp://hdl.handle.net/11449/71864
dc.language.isoeng
dc.relation.ispartofRevista Brasileira de Medicina
dc.relation.ispartofsjr0,101
dc.rights.accessRightsAcesso aberto
dc.sourceScopus
dc.subjectCyproterone acetate
dc.subjectEthinylestradiol
dc.subjectHyperandrogenism
dc.subjectMenstrual irregularity
dc.subjectcyproterone acetate
dc.subjectethinylestradiol
dc.subjectoral contraceptive agent
dc.subjectabdominal erythema
dc.subjectadult
dc.subjectamenorrhea
dc.subjectasthenia
dc.subjectbody mass
dc.subjectbreakthrough bleeding
dc.subjectbreast tenderness
dc.subjectchloasma
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug induced headache
dc.subjectdrug safety
dc.subjectdrug synthesis
dc.subjectdysmenorrhea
dc.subjecterythema
dc.subjectfemale
dc.subjectgastrointestinal symptom
dc.subjectglucose blood level
dc.subjecthuman
dc.subjectleg edema
dc.subjectlibido
dc.subjectmajor clinical study
dc.subjectmenstrual cycle
dc.subjectmenstrual irregularity
dc.subjectmenstruation
dc.subjectmood change
dc.subjectpatient compliance
dc.subjectpatient satisfaction
dc.subjectpelvic erythema
dc.subjectrandomized controlled trial
dc.subjectside effect
dc.subjectsleep disorder
dc.subjectvital sign
dc.subjectwithdrawal bleeding
dc.titleClinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic originen
dc.typeArtigo

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