Profile of Brazilian Climacteric Women: the Brazilian Men... | NCT06872385

Studies
Profile of Brazilian Climacteric Women: the Brazilian Menopause Study

NCT06872385

Sponsor

Faculdade de Medicina do ABC

Status

Completed

Last Update Posted

Mar 12, 2025Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Menopause

Interventions

Answering a questionnaire

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2019Actual

Primary Completion Date

Feb 11, 2020Actual

Completion Date

Feb 11, 2020Actual

First Submitted Date

Jan 20, 2022

First Submission Date that Met QC Criteria

Mar 10, 2025

First Posted Date

Mar 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luciano de Melo Pompei', Auxiliary Professor at Gynecology Department, Faculdade de Medicina do ABCPrincipal Investigator

Lead Sponsor

Faculdade de Medicina do ABCOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cross-sectional study with 1,500 women between 45 and 65 years old. Women participate by answering questionnaires prepared to get information about their perceptions and knowledge about menopause, hormone therapy and other treatments for menopause.

Detailed Description

This is a cross-sectional study with 1,500 women between 45 and 65 years old. The subjects participate by answering online questionnaires prepared to get information about their perceptions and knowledge about menopause, hormone therapy and other treatments for menopause. The distribution of subjects respect the distribution of Brazilian population according to country regions and according to socioeconomic class, and taking into account the information of last official Brazilian demographic census.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects		Women who meet the inclusion criteria and answered the questionnaire	Other: Answering a questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Answering a questionnaire	Other	The subject have to answer an online questionnaire about her perceptions on menopause and opinion on treatments for the condition	Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Answer to the questionnaire	Subject has to answer the questionnaire with several questions about her heath condition, age at menopause, treatments used for menopause	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women between 45 and 65 years of age
Women able to participate in a questionnaire on a digital platform and who have a device allowing this access

Exclusion Criteria:

Pregnant or lactating women

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Women aged between 45 and 65 years who accept to answer an online questionnaire in order to known their opinions on menopause and treatments for menopause, specially hormone therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciano M Pompei	Faculdade de Medicina do ABC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculdade de Medicina do ABC		Santo André	São Paulo	09060650	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided