Efficacy and safety of ultra-low-dose estradiol and norethisterone in postmenopausal Brazilian women

Página do item simplificado
dc.contributor.authorBonassi Machado, R.
dc.contributor.authorPompei, L. de Melo
dc.contributor.authorNahas, E. A.P. [UNESP]
dc.contributor.authorNahas-Neto, J. [UNESP]
dc.contributor.authorCosta-Paiva, L. da
dc.contributor.authorDel Debbio, S. Y.O.
dc.contributor.authorBadalotti, M.
dc.contributor.authorWender, M. C.O.
dc.contributor.authorCruz, A. M.
dc.contributor.institutionJundiai School of Medicine
dc.contributor.institutionABC School of Medicine
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionUniversidade Estadual de Campinas (UNICAMP)
dc.contributor.institutionCEPIC
dc.contributor.institutionPUC-RS
dc.contributor.institutionUFRGS–Federal University of Rio Grande do Sul
dc.contributor.institutionLibbs Farmacêutica Ltda
dc.date.accessioned2023-07-29T13:50:09Z
dc.date.available2023-07-29T13:50:09Z
dc.date.issued2023-01-01
dc.description.abstractObjective: This study aimed to evaluate the efficacy and safety of oral ultra-low-dose continuous combination of 17β-estradiol (17β-E2) and norethisterone acetate (NETA) in postmenopausal Brazilian women. Methods: Postmenopausal women (age 45–60 years) with amenorrhea >12 months and intact uterus, with moderate to severe vasomotor symptoms, were included. The vasomotor symptoms and endometrial bleeding were evaluated by a daily diary for 24 weeks, and the women were assessed at baseline and endpoint. Results: A total of 118 women were included. The group treated with 0.5 mg 17β-E2/0.1 mg NETA (n = 58) showed a percentage reduction of 77.1% in the frequency of vasomotor symptoms versus 49.9% in the placebo group (n = 60) (p = 0.0001). The severity score showed a reduction in the treatment group when compared to the placebo (p < 0.0001). The adverse events were comparable between the groups; however, in the 0.5 mg 17β-E2/0.1 mg NETA group there were more complaints of vaginal bleeding; despite that, in most cycles in both treatment groups, more than 80% of women experienced amenorrhea. Conclusions: The combination of 0.5 mg 17β-E2/0.1 mg NETA in a continuous combination regimen was shown to be effective in reducing the frequency and severity of vasomotor symptoms in Brazilian postmenopausal women.en
dc.description.affiliationDepartment of Gynecology and Obstetrics Jundiai School of Medicine
dc.description.affiliationDepartment of Gynecology and Obstetrics ABC School of Medicine
dc.description.affiliationDepartment of Gynecology and Obstetrics Botucatu School of Medicine UNESP–Sao Paulo State University
dc.description.affiliationDepartment of Obstetrics and Gynecology State University of Campinas
dc.description.affiliationPaulista Center for Clinical Research CEPIC
dc.description.affiliationDepartment of Gynecology and Obstetrics PUC-RS
dc.description.affiliationDepartment of Obstetrics and Gynecology School of Medicine UFRGS–Federal University of Rio Grande do Sul
dc.description.affiliationDepartment of Clinical Research Libbs Farmacêutica Ltda
dc.description.affiliationUnespDepartment of Gynecology and Obstetrics Botucatu School of Medicine UNESP–Sao Paulo State University
dc.identifierhttp://dx.doi.org/10.1080/13697137.2023.2190507
dc.identifier.citationClimacteric.
dc.identifier.doi10.1080/13697137.2023.2190507
dc.identifier.issn1473-0804
dc.identifier.issn1369-7137
dc.identifier.scopus2-s2.0-85152065467
dc.identifier.urihttp://hdl.handle.net/11449/248661
dc.language.isoeng
dc.relation.ispartofClimacteric
dc.sourceScopus
dc.subjectefficacy
dc.subjecthormone therapy
dc.subjectPostmenopausal women
dc.subjectsafety
dc.subjectultra-low-dose estradiol
dc.titleEfficacy and safety of ultra-low-dose estradiol and norethisterone in postmenopausal Brazilian womenen
dc.typeArtigo
unesp.author.orcid0000-0001-9361-0905[1]
unesp.author.orcid0000-0001-7084-037X[2]
unesp.author.orcid0000-0002-0803-8535[3]
unesp.author.orcid0000-0002-4662-5378[4]
unesp.author.orcid0000-0002-9088-6700[5]
unesp.author.orcid0000-0003-2597-1877[6]
unesp.author.orcid0000-0003-0770-8311[7]
unesp.author.orcid0000-0001-9085-4605[8]
unesp.author.orcid0000-0001-6655-5875[9]

Arquivos

Coleções

Artigos - Ginecologia e Obstetrícia - FMB