NCT04995276

Brief Summary

This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

July 23, 2021

Last Update Submit

April 5, 2022

Conditions

Menopause

Keywords

menopause

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular death

    up to 2025

  • Coronary heart disease

    up to 2025

  • Stroke

    up to 2025

Secondary Outcomes (4)

  • Diabetes mellitus

    up to 2025

  • Osteoporotic fractures

    up to 2025

  • Breast cancer

    up to 2025

  • Any cancer

    up to 2025

Eligibility Criteria

Age15 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include 4.000 postmenopausal women

You may qualify if:

  • Postmenopausal women

You may not qualify if:

  • Men Women of reproductive age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menopause Clinic, Aretaieio Hospital

Athens, Attica, 11528, Greece

RECRUITING

Central Study Contacts

Irene Lambrinoudaki, Prof.

CONTACT

6977005321ilambrinoudaki@med.uoa.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 6, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2025

Study Completion

December 31, 2025

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)