Clinical trial NCT07005648: Brazilian Registry of Menopausal
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Menopause
Keywords: Menopause
Post Menopause
Menopause Transition
Climateric
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 1592
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cisgender women or transgender men who have not undergone surgical or hormonal reassignment of secondary sexual characteristics, aged between 35 and 65 years, seeking outpatient care in public or private healthcare services.

Brief summary: This national study aims to better understand the health and quality of life of Brazilian women aged 35 to 65 who are in the menopausal transition or postmenopausal phase, including cisgender women and transgender men who have not undergone surgical or hormonal reassignment of secondary sexual characteristics. The study's hypothesis is that significant regional and socioeconomic disparities influence individuals' health, knowledge, and perception of menopause.

Detailed description: This is a descriptive, 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 women 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of women aged 35 to 65 classified as being in the menopausal transition or postmenopause.
timeFrame: Day 1 (during the medical appointment)
Secondary outcomes:
measure: Proportion of women in each menopausal status
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of the clinical profile
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of knowledge and self-perception of menopause
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of the anthropometric and physiological profile
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of General Health Profile
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of Laboratory Profile
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of the social profile
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of the demographic profile
timeFrame: Day 1 (during the medical appointment)
measure: Characterization of lifestyle profile
timeFrame: Day 1 (during the medical appointment)
measure: 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]
timeFrame: Day 1 (during the medical appointment)
measure: Total score and quantitative domains of the SF-36 questionnaire [36-Item Short-Form Health Survey]
timeFrame: Day 1 (during the medical appointment)
measure: Total score and quantitative domains of the WPAI-GH questionnaire [WPAI-GH (Work Productivity and Activity Impairment - General Health)]
timeFrame: Day 1 (during the medical appointment)
measure: Classification of anxiety according to the GAD-7 questionnaire [Generalized Anxiety Disorder scale]
timeFrame: Day 1 (during the medical appointment)
measure: Classification of depression according to the PHQ-9 questionnaire [Patient Health Questionnaire-9 (PHQ-9)]
timeFrame: Day 1 (during the medical appointment)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro de Pesquisa Unidade Morumbi - Science Valley Research Institute
Study officials:
affiliation: Science Valley Research Institute
name: Fabiane B de Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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, Rodrigues MAH, Albernaz MA, Decoud MSP, Paiva MSMO, Sanchez-Zambrano MB, Campos MDSB, Acevedo M, Ramirez MS, Souza OF, Medeiros OO, Carvalho RCM, Machado RB, Silva SCTFD, Rodrigues TCV, Avila WS, Costa-Paiva LHSD, Wender MCO. Brazilian Guideline on Menopausal Cardiovascular Health - 2024. Arq Bras Cardiol. 2024 Aug 16;121(7):e20240478. doi: 10.36660/abc.20240478. No abstract available. English, Portuguese.
citation: Duralde ER, Sobel TH, Manson JE. Management of perimenopausal and menopausal symptoms. BMJ. 2023 Aug 8;382:e072612. doi: 10.1136/bmj-2022-072612.