Brazilian Registry of Menopausal Health

Официальное название

Population-based Cross-sectional Observational Study for a Brazilian Registry of Menopausal Women and Associated Factors Related to Clinical Profile, Socioeconomic Aspects, Social Disparities, Access to Healthcare, Quality of Life, and Knowledge About Menopause

Обзор

The Brazilian Registry of Menopausal Health is a national study aimed to better understand the health and quality of life of participants aged 35 to 65 who are in the menopausal transition or postmenopausal phase, including cisgender women and transgender men. The study's hypothesis is that significant regional and socioeconomic disparities influence individuals' health, knowledge, and perception of menopause.

Подробное описание

The Brazilian Registry of Menopausal Health, called EMBRACE STUDY (Endrocrine Mapping in the Broad Range Of Aging and Climateric Experiences), is an observational, cross-sectional, population-based study conducted with the objective of characterizing the epidemiological aspects of the Brazilian population during the menopausal transition and postmenopause, as well as the factors associated with clinical profiles and symptomatology, socioeconomic conditions, social inequalities, access to healthcare services, quality of life, and knowledge about menopause.

The study will include cisgender women and transgender men who have not undergone surgical or hormonal gender reassignment of secondary sexual characteristics, aged between 35 and 65 years, who seek outpatient care in public or private healthcare services.

A total of 1,592 participants will be enrolled, with 617, 509, and 466 participants in the respective age groups of 35-44, 45-54, and 55-65 years, proportionally stratified across the 27 state capitals of Brazil. These age groups will be used solely for the purpose of sample stratification.

Data about transgender men will be collected for exploratory purposes.

Первичные конечные точки

• Proportion of participants aged 35 to 65 classified as being in the menopausal transition or postmenopause. [Срок оценки: Day 1 (during the medical appointment)]

Вторичные конечные точки (12)

• Proportion of participants in each menopausal status. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of the clinical profile. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of knowledge and self-perception of menopause. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of the anthropometric and physiological profile. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of General Health Profile. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of Laboratory Profile. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of the social profile. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of the demographic profile. [Срок оценки: Day 1 (during the medical appointment)]
• Characterization of lifestyle profile. [Срок оценки: Day 1 (during the medical appointment)]
• Total score and quantitative domains of the QSM/WHQ questionnaire [Women's Health Questionnaire (WHQ) / Questionário da Saúde da Mulher (QSM); applicable to women aged 45 to 65 years]. [Срок оценки: Day 1 (during the medical appointment)]
• Total score and quantitative domains of the SF-36 questionnaire [36-Item Short-Form Health Survey]. [Срок оценки: Day 1 (during the medical appointment)]
• Total score and quantitative domains of the WPAI-GH questionnaire [WPAI-GH (Work Productivity and Activity Impairment - General Health)]. [Срок оценки: Day 1 (during the medical appointment)]

Критерии участия

Критерии включения

• Women aged between 35 and 65 years attending medical consultation at public and private outpatient health services;
• Ability to confirm voluntary participation and sign the Informed Consent Form

Критерии исключения

• Inability to respond to the interview for any reason
• Suspected or confirmed pregnancy
• Lactation
• Uncontrolled diabetes
• Uncontrolled arterial hypertension
• Uncontrolled thyroid disorders
• Grade 3 obesity, defined by a BMI equal to or greater than 40.0 kg/m²
• Diagnosis of psychiatric disorders that may compromise participation in the interview
• Previous hysterectomy
• Previous oophorectomy
• Current use of illicit drugs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 1 центр

• Centro de Pesquisa Unidade Morumbi - Science Valley Research Institute — São Paulo

Публикации

• Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006. PMID 21961716
• Flores VA, Pal L, Manson JE. Hormone Therapy in Menopause: Concepts, Controversies, and Approach to Treatment. Endocr Rev. 2021 Nov 16;42(6):720-752. doi: 10.1210/endrev/bnab011. PMID 33858012
• Mehta J, Kling JM, Manson JE. Risks, Benefits, and Treatment Modalities of Menopausal Hormone Therapy: Current Concepts. Front Endocrinol (Lausanne). 2021 Mar 26;12:564781. doi: 10.3389/fendo.2021.564781. eCollection 2021. PMID 33841322
• Davis SR, Taylor S, Hemachandra C, Magraith K, Ebeling PR, Jane F, Islam RM. The 2023 Practitioner's Toolkit for Managing Menopause. Climacteric. 2023 Dec;26(6):517-536. doi: 10.1080/13697137.2023.2258783. Epub 2023 Dec 1. PMID 37902335
• Oliveira GMM, Almeida MCC, Arcelus CMA, Neto Espindola L, Rivera MAM, Silva-Filho ALD, Marques-Santos C, Fernandes CE, Albuquerque CJDM, Freire CMV, Izar MCO, Costa MENC, Castro ML, Lemke VMG, Lucena AJG, Brandao AA, Macedo AVS, Polanczyk CA, Lantieri CJB, Nahas EP, Alexandre ERG, Campana EMG, Braganca EOV, Colombo FMC, Barbosa ICQ, Rivera IR, Kulak J, Moura LAZ, Pompei LM, Baccaro LFC, Barbosa MM PMID 39166619
• Duralde ER, Sobel TH, Manson JE. Management of perimenopausal and menopausal symptoms. BMJ. 2023 Aug 8;382:e072612. doi: 10.1136/bmj-2022-072612. PMID 37553173
• Pompei LM, Bonassi-Machado R, Steiner ML, Pompei IM, de Melo NR, Nappi RE, Fernandes CE. Profile of Brazilian climacteric women: results from the Brazilian Menopause Study. Climacteric. 2022 Oct;25(5):523-529. doi: 10.1080/13697137.2022.2088276. Epub 2022 Jul 8. PMID 35801642

Идентификаторы

NCT: NCT07005648 · EMBRACE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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