Brazilian Registry of Menopausal Health

Science Valley Research Institute

Status: Not yet enrolling

Conditions: Menopause

Study type: Observational

Funder types: Other

Identifiers

NCT07005648

RENEW

Details and patient eligibility

About

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.

Full description

The Brazilian Registry of Menopausal Health, called RENEW (Registry of ENdocrine Changes in midlifE Women), 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.

Enrollment: 1,592 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,592 participants in 3 patient groups

617 participants = 35 to 44 years old

509 participants = 45 to 54 years old

466 participants = 55 to 65 years old