Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin
Autor(a) principal: | |
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Data de Publicação: | 2010 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4443 http://hdl.handle.net/11449/71864 |
Resumo: | We 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. |
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Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic originCyproterone acetateEthinylestradiolHyperandrogenismMenstrual irregularitycyproterone acetateethinylestradioloral contraceptive agentabdominal erythemaadultamenorrheaastheniabody massbreakthrough bleedingbreast tendernesschloasmaclinical trialcontrolled clinical trialcontrolled studydouble blind proceduredrug efficacydrug induced headachedrug safetydrug synthesisdysmenorrheaerythemafemalegastrointestinal symptomglucose blood levelhumanleg edemalibidomajor clinical studymenstrual cyclemenstrual irregularitymenstruationmood changepatient compliancepatient satisfactionpelvic erythemarandomized controlled trialside effectsleep disordervital signwithdrawal bleedingWe 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.FMT-UNIFESOUniversidade Estadual de São Paulo (UNESP)Serviço de Ginecologia Oncológica Hospital Mário PenaUFFInstituto Fernandes FigueiraServiço de Ginecologia Oncológica Hospital São José Serviço de Ginecologia do HCTCOUniversidade Estácio de Sa Pós-graduada em Gestão Hospitalar Centro Universitário Serra Dos ÓrgãosUNIFESOInstituto de Pós-Gradução Médica Carlos ChagasUFRJCentro de Ciências da Saúde UNIFESOUERJUniversidade Estadual de São Paulo (UNESP)FMT-UNIFESOUniversidade Estadual Paulista (Unesp)Hospital Mário PenaUFFInstituto Fernandes FigueiraServiço de Ginecologia do HCTCOCentro Universitário Serra Dos ÓrgãosUNIFESOInstituto de Pós-Gradução Médica Carlos ChagasUniversidade Federal do Rio de Janeiro (UFRJ)Universidade do Estado do Rio de Janeiro (UERJ)Gama, Carlos Romualdo Barbosa [UNESP]Gama, Gustavo FalcãoLasmar, Ricardo BasilFonseca, Rogerio SergioGuimarães, Lucia CunegattoDe Aquino, SabrinaGeller, MauroRibeiro, Rachel Leite2014-05-27T11:24:47Z2014-05-27T11:24:47Z2010-09-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article319-325http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4443Revista Brasileira de Medicina, v. 67, n. 9, p. 319-325, 2010.0034-7264http://hdl.handle.net/11449/718642-s2.0-77958060948Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengRevista Brasileira de Medicina0,101info:eu-repo/semantics/openAccess2021-10-22T19:44:39Zoai:repositorio.unesp.br:11449/71864Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T14:01:18.549447Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
title |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
spellingShingle |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin Gama, Carlos Romualdo Barbosa [UNESP] Cyproterone acetate Ethinylestradiol Hyperandrogenism Menstrual irregularity cyproterone acetate ethinylestradiol oral contraceptive agent abdominal erythema adult amenorrhea asthenia body mass breakthrough bleeding breast tenderness chloasma clinical trial controlled clinical trial controlled study double blind procedure drug efficacy drug induced headache drug safety drug synthesis dysmenorrhea erythema female gastrointestinal symptom glucose blood level human leg edema libido major clinical study menstrual cycle menstrual irregularity menstruation mood change patient compliance patient satisfaction pelvic erythema randomized controlled trial side effect sleep disorder vital sign withdrawal bleeding |
title_short |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
title_full |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
title_fullStr |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
title_full_unstemmed |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
title_sort |
Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin |
author |
Gama, Carlos Romualdo Barbosa [UNESP] |
author_facet |
Gama, Carlos Romualdo Barbosa [UNESP] Gama, Gustavo Falcão Lasmar, Ricardo Basil Fonseca, Rogerio Sergio Guimarães, Lucia Cunegatto De Aquino, Sabrina Geller, Mauro Ribeiro, Rachel Leite |
author_role |
author |
author2 |
Gama, Gustavo Falcão Lasmar, Ricardo Basil Fonseca, Rogerio Sergio Guimarães, Lucia Cunegatto De Aquino, Sabrina Geller, Mauro Ribeiro, Rachel Leite |
author2_role |
author author author author author author author |
dc.contributor.none.fl_str_mv |
FMT-UNIFESO Universidade Estadual Paulista (Unesp) Hospital Mário Pena UFF Instituto Fernandes Figueira Serviço de Ginecologia do HCTCO Centro Universitário Serra Dos Órgãos UNIFESO Instituto de Pós-Gradução Médica Carlos Chagas Universidade Federal do Rio de Janeiro (UFRJ) Universidade do Estado do Rio de Janeiro (UERJ) |
dc.contributor.author.fl_str_mv |
Gama, Carlos Romualdo Barbosa [UNESP] Gama, Gustavo Falcão Lasmar, Ricardo Basil Fonseca, Rogerio Sergio Guimarães, Lucia Cunegatto De Aquino, Sabrina Geller, Mauro Ribeiro, Rachel Leite |
dc.subject.por.fl_str_mv |
Cyproterone acetate Ethinylestradiol Hyperandrogenism Menstrual irregularity cyproterone acetate ethinylestradiol oral contraceptive agent abdominal erythema adult amenorrhea asthenia body mass breakthrough bleeding breast tenderness chloasma clinical trial controlled clinical trial controlled study double blind procedure drug efficacy drug induced headache drug safety drug synthesis dysmenorrhea erythema female gastrointestinal symptom glucose blood level human leg edema libido major clinical study menstrual cycle menstrual irregularity menstruation mood change patient compliance patient satisfaction pelvic erythema randomized controlled trial side effect sleep disorder vital sign withdrawal bleeding |
topic |
Cyproterone acetate Ethinylestradiol Hyperandrogenism Menstrual irregularity cyproterone acetate ethinylestradiol oral contraceptive agent abdominal erythema adult amenorrhea asthenia body mass breakthrough bleeding breast tenderness chloasma clinical trial controlled clinical trial controlled study double blind procedure drug efficacy drug induced headache drug safety drug synthesis dysmenorrhea erythema female gastrointestinal symptom glucose blood level human leg edema libido major clinical study menstrual cycle menstrual irregularity menstruation mood change patient compliance patient satisfaction pelvic erythema randomized controlled trial side effect sleep disorder vital sign withdrawal bleeding |
description |
We 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. |
publishDate |
2010 |
dc.date.none.fl_str_mv |
2010-09-01 2014-05-27T11:24:47Z 2014-05-27T11:24:47Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4443 Revista Brasileira de Medicina, v. 67, n. 9, p. 319-325, 2010. 0034-7264 http://hdl.handle.net/11449/71864 2-s2.0-77958060948 |
url |
http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4443 http://hdl.handle.net/11449/71864 |
identifier_str_mv |
Revista Brasileira de Medicina, v. 67, n. 9, p. 319-325, 2010. 0034-7264 2-s2.0-77958060948 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Revista Brasileira de Medicina 0,101 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
319-325 |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
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1808128304119545856 |