Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Repositório Institucional da UNIFESP |
Texto Completo: | https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=10028030 https://hdl.handle.net/11600/64829 |
Resumo: | BACKGROUND: Although several studies have been using transdermal testosterone, associated or not with estrogen therapy, as one of the treatments for the complaint of Hypoactive Sexual Desire Disorder (HSDD), there is still no consensus on its use in menacme, on effective dose, side effects or whether, in fact, there are positive results on the increase in libido. Several studies have also shown an improvement in quality of life, neurological cognition, general well-being and an improvement in depression in the populations studied with the use of testosterone replacement therapy. OBJECTIVE: To evaluate the effects of a nanostructured transdermal testosterone cream in the treatment of HSDD on the impact on quality of life, general well-being and sexuality, as well as its side effects, within 12 weeks in women at menacme. METHODOLOGY: Women (n = 52) with complaints of low sexual desire at the UNIFESP Endocrine Gynecology clinic were screened according to the inclusion and exclusion criteria. Participants were divided into two previously randomized groups, blood samples were collected for laboratory tests, completed the FSFI (Female Sexual Function Index) questionnaires, Beck's Depression Inventory (IDB) and WHOQOL-bref (shortened quality of life questionnaire). life and well-being) before and after the start of treatment, and were instructed to make daily use of the prescribed formulation (vehicle Biolipid with placebo or Biolipid with Testosterone 300mcg) according to the group to which they belonged. Participants and researchers remained blind until the end of the study of resultsPatients diagnosed with HSDD at UNIFESP Gynecology Clinic were screened according to the inclusion and exclusion criteria. Participants (n = 52) were divided into two groups randomly, blood samples were collected for laboratory tests, they completed the FSFI (Female Sexual Function Index) questionnaire, Beck's Depression Inventory (IDB) and WHOQOL-bref (short World Health Organization Quality of Life) before and after the start of treatment, and were xi instructed to make daily use of the vehicle formulation Biolipid with placebo or Biolipid with Testosterone 300mcg according to the group to which they belonged. As participants and researchers remained blind until the final analysis of the results. RESULTS: Group B (group that used the formulation containing testosterone 300mcg / puff) showed a significant increase in the scores of the FSFI desire, arousal, lubrication, orgasm, satisfaction and pain domains, this improvement being more evident in young patients. The placebo group also showed improvement, but with slightly less expressive results. Both groups showed improvement regarding depressive symptoms. There was a tendency to increase androgen dosages in group B, but without statistical difference. There was no significant change in quality of life and no serious side effects were observed. CONCLUSION: The formulation of Biolipid vehicle with Testosterone 300mcg transdermally showed positive effects on sexuality and symptoms of depression, without negative effects on quality of life, keeping plasma androgen levels within the normal range, although further studies are needed. |
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Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cegoTestosteroneQuality Of LifeWomenLibidoDepressionSkin CreamTestosteronaQualidade De VidaMulheresLibidoDepressãoCreme Para A PeleBACKGROUND: Although several studies have been using transdermal testosterone, associated or not with estrogen therapy, as one of the treatments for the complaint of Hypoactive Sexual Desire Disorder (HSDD), there is still no consensus on its use in menacme, on effective dose, side effects or whether, in fact, there are positive results on the increase in libido. Several studies have also shown an improvement in quality of life, neurological cognition, general well-being and an improvement in depression in the populations studied with the use of testosterone replacement therapy. OBJECTIVE: To evaluate the effects of a nanostructured transdermal testosterone cream in the treatment of HSDD on the impact on quality of life, general well-being and sexuality, as well as its side effects, within 12 weeks in women at menacme. METHODOLOGY: Women (n = 52) with complaints of low sexual desire at the UNIFESP Endocrine Gynecology clinic were screened according to the inclusion and exclusion criteria. Participants were divided into two previously randomized groups, blood samples were collected for laboratory tests, completed the FSFI (Female Sexual Function Index) questionnaires, Beck's Depression Inventory (IDB) and WHOQOL-bref (shortened quality of life questionnaire). life and well-being) before and after the start of treatment, and were instructed to make daily use of the prescribed formulation (vehicle Biolipid with placebo or Biolipid with Testosterone 300mcg) according to the group to which they belonged. Participants and researchers remained blind until the end of the study of resultsPatients diagnosed with HSDD at UNIFESP Gynecology Clinic were screened according to the inclusion and exclusion criteria. Participants (n = 52) were divided into two groups randomly, blood samples were collected for laboratory tests, they completed the FSFI (Female Sexual Function Index) questionnaire, Beck's Depression Inventory (IDB) and WHOQOL-bref (short World Health Organization Quality of Life) before and after the start of treatment, and were xi instructed to make daily use of the vehicle formulation Biolipid with placebo or Biolipid with Testosterone 300mcg according to the group to which they belonged. As participants and researchers remained blind until the final analysis of the results. RESULTS: Group B (group that used the formulation containing testosterone 300mcg / puff) showed a significant increase in the scores of the FSFI desire, arousal, lubrication, orgasm, satisfaction and pain domains, this improvement being more evident in young patients. The placebo group also showed improvement, but with slightly less expressive results. Both groups showed improvement regarding depressive symptoms. There was a tendency to increase androgen dosages in group B, but without statistical difference. There was no significant change in quality of life and no serious side effects were observed. CONCLUSION: The formulation of Biolipid vehicle with Testosterone 300mcg transdermally showed positive effects on sexuality and symptoms of depression, without negative effects on quality of life, keeping plasma androgen levels within the normal range, although further studies are needed.JUSTIFICATIVA: Embora diversos estudos venham utilizando testosterona transdérmica, associado ou não a estrogenioterapia, como um dos tratamentos para a queixa de diminuição do desejo sexual hipoativo (DSH), ainda não há consenso sobre o seu uso no menacme, sobre dose efetiva, efeitos colaterais ou se, de fato, há resultados positivos sobre o aumento da libido. Diversos estudos também demonstraram uma melhora na qualidade de vida, na cognição neurológica, no bem- estar geral e na melhora da depressão das populações estudadas com o uso da terapia de reposição de testosterona. OBJETIVO: Avaliar os efeitos de um creme de testosterona transdérmica nanoestruturada no tratamento do DSH sobre a repercussão na qualidade de vida, bem-estar geral e na sexualidade, bem como seus efeitos colaterais, no prazo de 12 semanas em mulheres no menacme. METODOLOGIA: Mulheres (n=52) com queixa de baixo desejo sexual do ambulatório de Ginecologia Endócrina da UNIFESP foram triadas de acordo com os critérios de inclusão e exclusão. As participantes foram divididas em dois grupos previamente randomizados, foram coletadas amostras de sangue para realização de exames laboratoriais, preencheram os questionários FSFI (Female Sexual Function Index), Inventário de Depressão de Beck (IDB) e WHOQOL-bref (questionário abreviado de qualidade de vida e bem estar) antes e depois do início do tratamento, e foram orientadas a fazer uso diário da formulação prescrita (veículo Biolipídio com placebo ou Biolípidio com Testosterona 300mcg) de acordo com o grupo a que pertenciam. As participantes e os pesquisadores permaneceram cegos até o final do estudo dos resultados. RESULTADOS: O grupo B (grupo que fez uso da formulação contendo testosterona 300mcg/puff) apresentou aumento significativo nos escores dos domínios desejo, excitação, lubrificação, orgasmo, satisfação e dor do FSFI, sendo esta melhora mais evidente nas pacientes jovens. O grupo placebo também apresentou melhora, porém com resultados um pouco menos expressivos. Ambos os grupos apresentaram melhora com relação aos sintomas depressivos. Houve tendência a aumento das dosagens de androgênios no grupo B, porém sem diferença estatística. Não houve mudança significativa na qualidade de vida e nenhum efeito colateral grave foi observado. CONCLUSÃO: A formulação de veículo Biolipídio com Testosterona 300mcg por via transdérmica mostrou efeitos positivos na sexualidade e nos sintomas de depressão, sem efeitos negativos na qualidade de vida, mantendo os níveis de androgênios plasmáticos dentro da faixa da normalidade, embora mais estudos sejam necessários.Dados abertos - Sucupira - Teses e dissertações (2020)Universidade Federal de São Paulo (UNIFESP)Silva, Ivaldo Da [UNIFESP]Universidade Federal de São PauloMargato, Marcela Furlan [UNIFESP]2022-07-22T17:29:14Z2022-07-22T17:29:14Z2020-04-30info:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/publishedVersion78 p.application/pdfhttps://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=10028030MARCELA FURLAN MARGATO.pdfhttps://hdl.handle.net/11600/64829porinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-07-27T03:52:29Zoai:repositorio.unifesp.br/:11600/64829Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-07-27T03:52:29Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
dc.title.none.fl_str_mv |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
title |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
spellingShingle |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego Margato, Marcela Furlan [UNIFESP] Testosterone Quality Of Life Women Libido Depression Skin Cream Testosterona Qualidade De Vida Mulheres Libido Depressão Creme Para A Pele |
title_short |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
title_full |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
title_fullStr |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
title_full_unstemmed |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
title_sort |
Uso de testosterona transdérmica em mulheres no menacme com desejo sexual hipoativo e qualidade de vida: ensaio clínico randomizado duplo-cego |
author |
Margato, Marcela Furlan [UNIFESP] |
author_facet |
Margato, Marcela Furlan [UNIFESP] |
author_role |
author |
dc.contributor.none.fl_str_mv |
Silva, Ivaldo Da [UNIFESP] Universidade Federal de São Paulo |
dc.contributor.author.fl_str_mv |
Margato, Marcela Furlan [UNIFESP] |
dc.subject.por.fl_str_mv |
Testosterone Quality Of Life Women Libido Depression Skin Cream Testosterona Qualidade De Vida Mulheres Libido Depressão Creme Para A Pele |
topic |
Testosterone Quality Of Life Women Libido Depression Skin Cream Testosterona Qualidade De Vida Mulheres Libido Depressão Creme Para A Pele |
description |
BACKGROUND: Although several studies have been using transdermal testosterone, associated or not with estrogen therapy, as one of the treatments for the complaint of Hypoactive Sexual Desire Disorder (HSDD), there is still no consensus on its use in menacme, on effective dose, side effects or whether, in fact, there are positive results on the increase in libido. Several studies have also shown an improvement in quality of life, neurological cognition, general well-being and an improvement in depression in the populations studied with the use of testosterone replacement therapy. OBJECTIVE: To evaluate the effects of a nanostructured transdermal testosterone cream in the treatment of HSDD on the impact on quality of life, general well-being and sexuality, as well as its side effects, within 12 weeks in women at menacme. METHODOLOGY: Women (n = 52) with complaints of low sexual desire at the UNIFESP Endocrine Gynecology clinic were screened according to the inclusion and exclusion criteria. Participants were divided into two previously randomized groups, blood samples were collected for laboratory tests, completed the FSFI (Female Sexual Function Index) questionnaires, Beck's Depression Inventory (IDB) and WHOQOL-bref (shortened quality of life questionnaire). life and well-being) before and after the start of treatment, and were instructed to make daily use of the prescribed formulation (vehicle Biolipid with placebo or Biolipid with Testosterone 300mcg) according to the group to which they belonged. Participants and researchers remained blind until the end of the study of resultsPatients diagnosed with HSDD at UNIFESP Gynecology Clinic were screened according to the inclusion and exclusion criteria. Participants (n = 52) were divided into two groups randomly, blood samples were collected for laboratory tests, they completed the FSFI (Female Sexual Function Index) questionnaire, Beck's Depression Inventory (IDB) and WHOQOL-bref (short World Health Organization Quality of Life) before and after the start of treatment, and were xi instructed to make daily use of the vehicle formulation Biolipid with placebo or Biolipid with Testosterone 300mcg according to the group to which they belonged. As participants and researchers remained blind until the final analysis of the results. RESULTS: Group B (group that used the formulation containing testosterone 300mcg / puff) showed a significant increase in the scores of the FSFI desire, arousal, lubrication, orgasm, satisfaction and pain domains, this improvement being more evident in young patients. The placebo group also showed improvement, but with slightly less expressive results. Both groups showed improvement regarding depressive symptoms. There was a tendency to increase androgen dosages in group B, but without statistical difference. There was no significant change in quality of life and no serious side effects were observed. CONCLUSION: The formulation of Biolipid vehicle with Testosterone 300mcg transdermally showed positive effects on sexuality and symptoms of depression, without negative effects on quality of life, keeping plasma androgen levels within the normal range, although further studies are needed. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-04-30 2022-07-22T17:29:14Z 2022-07-22T17:29:14Z |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=10028030 MARCELA FURLAN MARGATO.pdf https://hdl.handle.net/11600/64829 |
url |
https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=10028030 https://hdl.handle.net/11600/64829 |
identifier_str_mv |
MARCELA FURLAN MARGATO.pdf |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
78 p. application/pdf |
dc.publisher.none.fl_str_mv |
Universidade Federal de São Paulo (UNIFESP) |
publisher.none.fl_str_mv |
Universidade Federal de São Paulo (UNIFESP) |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
instname_str |
Universidade Federal de São Paulo (UNIFESP) |
instacron_str |
UNIFESP |
institution |
UNIFESP |
reponame_str |
Repositório Institucional da UNIFESP |
collection |
Repositório Institucional da UNIFESP |
repository.name.fl_str_mv |
Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP) |
repository.mail.fl_str_mv |
biblioteca.csp@unifesp.br |
_version_ |
1814268376786141184 |