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Recruiting NCT07005648

Brazilian Registry of Menopausal Health

— Observational Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Menopause. Basic parameters: 35 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Proportion of participants aged 35 to 65 classified as being in the menopausal transition or postmenopause. [Time frame: Day 1 (during the medical appointment)]
Secondary outcome measures (12)
  • Proportion of participants in each menopausal status. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of the clinical profile. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of knowledge and self-perception of menopause. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of the anthropometric and physiological profile. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of General Health Profile. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of Laboratory Profile. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of the social profile. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of the demographic profile. [Time frame: Day 1 (during the medical appointment)]
  • Characterization of lifestyle profile. [Time frame: 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]. [Time frame: Day 1 (during the medical appointment)]
  • Total score and quantitative domains of the SF-36 questionnaire [36-Item Short-Form Health Survey]. [Time frame: 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)]. [Time frame: Day 1 (during the medical appointment)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Centro de Pesquisa Unidade Morumbi - Science Valley Research Institute — São Paulo

Publications

  • 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

Identifiers

NCT: NCT07005648 · EMBRACE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗