O impacto da nanoemulsão de testosterona transdérmica sobre o perfil lipídico em mulheres com desejo sexual hipoativo: estudo duplo-cego controlado e randomizado
Data
2022-03-22
Tipo
Dissertação de mestrado
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ISSN da Revista
Título de Volume
Resumo
Objetivo: Observar o efeito do uso da nanoemulsão de testosterona de uso transdérmico quanto à resposta da função sexual feminina e o seu efeito sobre o perfil lipídico das pacientes no menacme com diagnóstico de desejo sexual hipoativo (DSH).
Métodos: Selecionadas de modo randomizado 52 pacientes dos ambulatórios de Ginecologia da Universidade Federal de São Paulo. Todas obedeceram aos critérios de inclusão e exclusão, sendo fundamental apresentar idade entre 18 a 45 anos e terem diagnóstico de Desejo Sexual Hipoativo. As pacientes foram divididas de forma duplamente cega em dois grupos: Um grupo recebeu emulsão de biolípídeo (placebo) e outro grupo recebeu a nanoemulsão de biolipídeo com testosterona na dose de 300 microgramas / puff; ambos os grupos receberam a orientação de usar 1 puff diário na pele. Todas as voluntárias foram submetidas a 12 semanas de tratamento com o uso tópico das nanoemulsões de biolipídeo. Para a avaliação, segundo os objetivos deste estudo clínico duplo-cego e randomizado, foram realizados exames laboratoriais, exame físico e aplicado o questionário de Índice de Função sexual no início (antes do tratamento) e ao fim de 12 semanas. A cada 4 semanas as pacientes eram acompanhadas com o objetivo de identificar o surgimento de efeitos colaterais. Todos os pacientes e o pesquisador mantiveram-se cegos durante a seleção e tratamento dos pacientes, até a análise dos dados.
Resultados: Os grupos foram homogêneos na seleção quando avaliadas as variáveis sócio-culturais e étnicas que discriminavam as participantes para cada grupo. Todas as pacientes melhoraram os escores do Índice de Função sexual, sem diferença estatística significante entre Grupo Teste e Grupo Placebo, com p-valor de 0,05 considerado para as análises. Não houve impacto do uso da testosterona na dose de 300 microgramas via transdérmica sobre o metabolismo lipídico ou mesmo sobre a função hepática dos participantes. Nenhuma das pacientes apresentou efeitos colaterais indesejados.
Conclusões: O uso de testosterona transdérmica na dose de 300 microgramas não teve efeito sobre a função sexual das mulheres com DSH. O número limitado de pacientes participantes ou a dose pode ter sido fator preponderante para este resultado. As segurança sobre o metabolismo lipídico e hepático, bem como a ausência de efeitos colaterais, pode permitir a reprodução do estudo com maior número de participantes. O fato de todas as pacientes obterem melhora do Índice de Função Sexual permite inferir que o contato com o Serviço de Saúde e o acesso à assistência têm papel relevante no tratamento desses pacientes.
Descritores: Disfunções sexuais psicogênicas, Desejo Sexual Ausente, Transtorno do Desejo Sexual Hipoativo, Libido, Congêneres da Testosterona, Globulina de Ligação a Hormônio Sexual, Testosterona, Lipídeos, Mulheres, Relações Interpessoais, Serviços de Saúde da Mulher, Saúde da Mulher.
Objective: To observe the effect of transdermal testosterone nanoemulsion on the response of Female sexual function and its effect on the lipid profile of menacme patients diagnosed with DSH. Methods: 52 patients were randomly selected from the Gynecology outpatient clinics of the Universidade Federal de São Paulo. All participants met the inclusion and exclusion criteria, being essential to be between 18 and 45 years old and have a diagnosis of Hypoactive Sexual Desire. The patients were divided in a double blind way into two groups; one group received biolipidic emulsion (placebo) and another group received the biolipidic nanoemulsion with testosterone at a dose of 300 micrograms/puff; both groups were instructed to use 1 daily puff on the skin. All volunteers underwent 12 weeks of treatment with the topical use of biolipidic nanoemulsions. For the evaluation, according to the objectives of this double-blind and randomized clinical study, laboratory tests, physical examination were performed, and the Sexual Function Index questionnaire was applied at the beginning (before treatment) and at the end of 12 weeks. Every 4 weeks, patients were followed in order to identify the emergence of side effects. All patients and the researcher remained blind during patient selection and treatment, until data analysis. Results: The groups were homogeneous in the selection when the socio-cultural and ethnic variables that discriminated the participants for each group were evaluated. All patients improved their Sexual Function Index scores, with no statistically significant difference between the Test Group and Placebo Group, with a p-value of 0.05 considered for the analyses. There was no impact of the use of testosterone at a dose of 300 micrograms, transdermally, on the lipid metabolism or even on the liver function of the participants. None of the patients had unwanted side effects. Conclusions: The use of transdermal testosterone at a dose of 300 micrograms had no effect on the sexual function of women with DSH. The limited number of participating patients or dose may have been a major factor for this result. The safety of lipid and liver metabolism, as well as the absence of side effects, may allow the study to be reproduced with a larger number of participants. The fact that all patients had an improvement in the Sexual Function Index allows us to infer that contact with the Health Service and access to care play a relevant role in the treatment of these patients. Keywords: Psychogenic Sexual Dysfunctions, Absent Sexual Desire, Hypoactive Sexual Desire Disorder, Libido, Testosterone Congeners, Sex Hormone Binding Globulin, Testosterone, Lipids, Women, Interpersonal Relations, Women's Health Services, Women's Health
Objective: To observe the effect of transdermal testosterone nanoemulsion on the response of Female sexual function and its effect on the lipid profile of menacme patients diagnosed with DSH. Methods: 52 patients were randomly selected from the Gynecology outpatient clinics of the Universidade Federal de São Paulo. All participants met the inclusion and exclusion criteria, being essential to be between 18 and 45 years old and have a diagnosis of Hypoactive Sexual Desire. The patients were divided in a double blind way into two groups; one group received biolipidic emulsion (placebo) and another group received the biolipidic nanoemulsion with testosterone at a dose of 300 micrograms/puff; both groups were instructed to use 1 daily puff on the skin. All volunteers underwent 12 weeks of treatment with the topical use of biolipidic nanoemulsions. For the evaluation, according to the objectives of this double-blind and randomized clinical study, laboratory tests, physical examination were performed, and the Sexual Function Index questionnaire was applied at the beginning (before treatment) and at the end of 12 weeks. Every 4 weeks, patients were followed in order to identify the emergence of side effects. All patients and the researcher remained blind during patient selection and treatment, until data analysis. Results: The groups were homogeneous in the selection when the socio-cultural and ethnic variables that discriminated the participants for each group were evaluated. All patients improved their Sexual Function Index scores, with no statistically significant difference between the Test Group and Placebo Group, with a p-value of 0.05 considered for the analyses. There was no impact of the use of testosterone at a dose of 300 micrograms, transdermally, on the lipid metabolism or even on the liver function of the participants. None of the patients had unwanted side effects. Conclusions: The use of transdermal testosterone at a dose of 300 micrograms had no effect on the sexual function of women with DSH. The limited number of participating patients or dose may have been a major factor for this result. The safety of lipid and liver metabolism, as well as the absence of side effects, may allow the study to be reproduced with a larger number of participants. The fact that all patients had an improvement in the Sexual Function Index allows us to infer that contact with the Health Service and access to care play a relevant role in the treatment of these patients. Keywords: Psychogenic Sexual Dysfunctions, Absent Sexual Desire, Hypoactive Sexual Desire Disorder, Libido, Testosterone Congeners, Sex Hormone Binding Globulin, Testosterone, Lipids, Women, Interpersonal Relations, Women's Health Services, Women's Health
Descrição
Citação
MELETTI, Natasha Ferreira Teixeira. O impacto da nanoemulsão de testosterona transdérmica sobre o perfil lipídico em mulheres com desejo sexual hipoativo: estudo duplo-cego controlado e randomizado. São Paulo, 2022. 72 f. Dissertação (Mestrado em Ginecologia) – Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2022.