Brazilian Registry of Menopausal Health
ConditionMenopause
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-65
SponsorScience Valley Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability to respond to the interview for any reason
Suspected or confirmed pregnancy
Lactation
Uncontrolled diabetes
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,592 Participants
are grouped into 3 trial groupsGroup A: 617 participants = 35 to 44 years old
Group B: 509 participants = 45 to 54 years old
Group C: 466 participants = 55 to 65 years old
Trial outcomes
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.
Time frame
Day 1 (during the medical appointment)Secondary outcomes
1
Proportion of participants in each menopausal status.
Premenopause; Menopausal transition; Postmenopause.
Time frame
Day 1 (during the medical appointment)2
Characterization of the clinical profile.
This outcome measure includes a structured assessment of variables related to the participant's gynecologic and clinical history: age at menarche, menstruation status, date of last menstruation, age at last menstruation, personal medical history, and comorbidities. These variables and the summary statistics (when applicable) will be aggregated to produce a standardized clinical profile report for each participant.
Time frame
Day 1 (during the medical appointment)3
Characterization of knowledge and self-perception of menopause.
This outcome measure includes a structured assessment of participants' understanding and personal perspective regarding menopause. The evaluation comprises the following elements: perception of menopause, definitions of menopause, history of hormone therapy (HT) use, perception and expectations regarding HT, and perceived impact of HT on menopause experience. These variables will be aggregated to generate a descriptive profile of knowledge and self-perception of menopause for each participant.
Time frame
Day 1 (during the medical appointment)4
Characterization of the anthropometric and physiological profile.
This outcome measure includes anthropometric and physiological parameters: weight (in kilograms), height (in centimeters), body mass index (BMI, calculated as weight/height² in kg/m²), waist circumference (in centimeters), hip circumference (in centimeters), and blood pressure (in mmHg). These variables will be aggregated to generate an anthropometric profile for each participant, allowing for descriptive and comparative analysis of body composition and cardiovascular markers.
Time frame
Day 1 (during the medical appointment)Other outcomes
1
Skin Physiological Characterization by Non-Invasive Instrumental and Digital Imaging Assessments
To characterize skin and hair physiological parameters in a subgroup of 150 participants at selected study centers using non-invasive instrumental assessments and high-resolution digital photography. Skin assessments will include hydration (corneometry), firmness and elasticity (cutometry), transepidermal water loss (TEWL; evaporimetry), skin pH (potentiometry), melanin and erythema indices (mexarametry), and skin tone and texture (high-resolution digital photography).
Time frame
Day 1 (during the medical appointment)2
Hair Morphological and Curvature Characterization by Digital Imaging
To characterize hair morphology and curvature in a subgroup of 150 participants at selected study centers using high-resolution digital photography.
Time frame
Day 1 (during the medical appointment)Sponsors and contacts
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Source ClinicalTrials.gov