Brazilian Registry of Menopausal Health

NCT07005648 | Not Yet Recruiting

• 1 other identifier: RENEW
• Study Type: observational
• Target: 1,592
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopause

Keywords

Menopause; Post Menopause; Menopause Transition; Climateric

Outcome Measures

Primary Outcomes (1)

• Proportion of participants aged 35 to 65 classified as being in the menopausal transition or postmenopause.

  Definition of menopausal status. Premenopause: regular menstrual cycles, corresponding to the reproductive period preceding menopause; Menopausal transition: characterized by irregular menstrual cycles and amenorrhea for less than 12 months. Postmenopause: amenorrhea for more than 12 months.

  Day 1 (during the medical appointment)

Secondary Outcomes (14)

• Proportion of participants in each menopausal status.

  Day 1 (during the medical appointment)

• Characterization of the clinical profile.

  Day 1 (during the medical appointment)

• Characterization of knowledge and self-perception of menopause.

  Day 1 (during the medical appointment)

• Characterization of the anthropometric and physiological profile.

  Day 1 (during the medical appointment)

• Characterization of General Health Profile.

  Day 1 (during the medical appointment)

Study Arms (3)

617 participants = 35 to 44 years old

509 participants = 45 to 54 years old

466 participants = 55 to 65 years old

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Cisgender women or transgender men who have not undergone surgical or hormonal reassignment of secondary sexual characteristics.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Science Valley Research Institute: lead

Study Sites (1)

Centro de Pesquisa Unidade Morumbi - Science Valley Research Institute

São Paulo, São Paulo, 05615-190, Brazil

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 39166619 BACKGROUND

• 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 BACKGROUND

Study Officials

• Fabiane B de Souza, MD

  Science Valley Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leandro Agati

CONTACT

+55 (11) 4468-8183; agati@svriglobal.com

Eduardo Ramacciotti, PhD

CONTACT

+55 (11) 99944-4544; ramacciotti@svriglobal.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: June 5, 2025
• Study Start: November 17, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

BR (1)