Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)

Detalhes bibliográficos
Autor(a) principal: Barbosa, Ione Cristina
Data de Publicação: 2006
Outros Autores: Isaia Filho, Carlos, Faggion Junior, Dirceu, Baracat, Edmund Chada
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://repositorio.ufba.br/ri/handle/ri/13469
Resumo: Texto completo: acesso restrito. p.30–33
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spelling Barbosa, Ione CristinaIsaia Filho, CarlosFaggion Junior, DirceuBaracat, Edmund ChadaBarbosa, Ione CristinaIsaia Filho, CarlosFaggion Junior, DirceuBaracat, Edmund Chada2013-11-01T11:46:33Z20060010-7824http://repositorio.ufba.br/ri/handle/ri/13469v.73 n. 1Texto completo: acesso restrito. p.30–33Objective: A prospective, open-label, noncomparative, multicenter study was carried out in 163 women aged 18–39 (mean 25±5 years), who used an ultra-low-dose oral contraceptive pill (OCP) containing gestodene (GTD) 60 μg/ethinylestradiol (EE) 15 μg for 6 months. The objective of the study was to evaluate the acceptability, safety, bleeding patterns and premenstrual symptomatology in these women. Methods: Patients used the OCP from Days 1–24, followed by a 4-day pill-free interval from Days 25–28 of the menstrual cycle. Physical and gynecological examinations were carried out at baseline and after 3 and 6 months, at which time blood pressure, weight, hemoglobin, hematocrit, SGOT, SGPT and urinalysis were also assessed. The Moos Menstrual Distress Questionnaire (MDQ) was completed on three consecutive days (Days 25–27 of the cycle) at baseline and at the end of the third and sixth cycles. Patients kept a menstrual diary throughout the study. Results: A total of 146 women completed the study. Ten women discontinued because of adverse events and one undesired pregnancy occurred during treatment. No adverse metabolic effects were observed. The adverse event most frequently reported was breakthrough bleeding, which diminished, however, as the time of OC use increased. Cycle length and duration of bleeding decreased significantly with OC use (p<.01 and p<.05, respectively, after 6 months). Intensity of menstrual bleeding tended to decrease with OC use, but this difference was not statistically significant. Systolic and diastolic blood pressure were significantly lower after 6 months of OC use compared to baseline (p<.02). No alterations were recorded in body weight or laboratory evaluations. Statistically significant changes were found both in the total MDQ score and in several of the factors evaluated, and patients showed a statistically significant improvement in well-being with respect to premenstrual complaints and symptoms. Conclusion: This OC regimen is safe, well-accepted and well-tolerated, affects menstrual patterns beneficially by reducing both the intensity and duration of bleeding, provides good cycle control and improves premenstrual symptomatology.Submitted by Edileide Reis (leyde-landy@hotmail.com) on 2013-09-05T13:43:35Z No. of bitstreams: 1 1-s2.0-S0010782405002544-main.pdf: 120003 bytes, checksum: ecc603b8ed2a1bef05ecde49884cb01a (MD5)Approved for entry into archive by Rodrigo Meirelles (rodrigomei@ufba.br) on 2013-11-01T11:46:33Z (GMT) No. of bitstreams: 1 1-s2.0-S0010782405002544-main.pdf: 120003 bytes, checksum: ecc603b8ed2a1bef05ecde49884cb01a (MD5)Made available in DSpace on 2013-11-01T11:46:33Z (GMT). No. of bitstreams: 1 1-s2.0-S0010782405002544-main.pdf: 120003 bytes, checksum: ecc603b8ed2a1bef05ecde49884cb01a (MD5) Previous issue date: 2006http://dx.doi.org.ez10.periodicos.capes.gov.br/10.1016/j.contraception.2005.06.057reponame:Repositório Institucional da UFBAinstname:Universidade Federal da Bahia (UFBA)instacron:UFBAContraceptivesMoos Menstrual Distress QuestionnaireEthinylestradiolGestodeneBleeding patternsProspective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)Contraceptioninfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10000-01-01info:eu-repo/semantics/openAccessengORIGINAL1-s2.0-S0010782405002544-main.pdf1-s2.0-S0010782405002544-main.pdfapplication/pdf120003https://repositorio.ufba.br/bitstream/ri/13469/1/1-s2.0-S0010782405002544-main.pdfecc603b8ed2a1bef05ecde49884cb01aMD51LICENSElicense.txtlicense.txttext/plain1762https://repositorio.ufba.br/bitstream/ri/13469/2/license.txt1b89a9a0548218172d7c829f87a0eab9MD52TEXT1-s2.0-S0010782405002544-main.pdf.txt1-s2.0-S0010782405002544-main.pdf.txtExtracted texttext/plain20826https://repositorio.ufba.br/bitstream/ri/13469/3/1-s2.0-S0010782405002544-main.pdf.txt04255cdc4cc0b39be426edeb45368b12MD53ri/134692022-08-08 13:17:35.411oai:repositorio.ufba.br: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Repositório InstitucionalPUBhttp://192.188.11.11:8080/oai/requestopendoar:19322022-08-08T16:17:35Repositório Institucional da UFBA - Universidade Federal da Bahia (UFBA)false
dc.title.pt_BR.fl_str_mv Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
dc.title.alternative.pt_BR.fl_str_mv Contraception
title Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
spellingShingle Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
Barbosa, Ione Cristina
Contraceptives
Moos Menstrual Distress Questionnaire
Ethinylestradiol
Gestodene
Bleeding patterns
title_short Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
title_full Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
title_fullStr Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
title_full_unstemmed Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
title_sort Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 μg and ethinylestradiol 15 μg (Minesse®)
author Barbosa, Ione Cristina
author_facet Barbosa, Ione Cristina
Isaia Filho, Carlos
Faggion Junior, Dirceu
Baracat, Edmund Chada
author_role author
author2 Isaia Filho, Carlos
Faggion Junior, Dirceu
Baracat, Edmund Chada
author2_role author
author
author
dc.contributor.author.fl_str_mv Barbosa, Ione Cristina
Isaia Filho, Carlos
Faggion Junior, Dirceu
Baracat, Edmund Chada
Barbosa, Ione Cristina
Isaia Filho, Carlos
Faggion Junior, Dirceu
Baracat, Edmund Chada
dc.subject.por.fl_str_mv Contraceptives
Moos Menstrual Distress Questionnaire
Ethinylestradiol
Gestodene
Bleeding patterns
topic Contraceptives
Moos Menstrual Distress Questionnaire
Ethinylestradiol
Gestodene
Bleeding patterns
description Texto completo: acesso restrito. p.30–33
publishDate 2006
dc.date.issued.fl_str_mv 2006
dc.date.accessioned.fl_str_mv 2013-11-01T11:46:33Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv http://repositorio.ufba.br/ri/handle/ri/13469
dc.identifier.issn.none.fl_str_mv 0010-7824
dc.identifier.number.pt_BR.fl_str_mv v.73 n. 1
identifier_str_mv 0010-7824
v.73 n. 1
url http://repositorio.ufba.br/ri/handle/ri/13469
dc.language.iso.fl_str_mv eng
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