Inflammation, Autoimmunity and Healthy Ageing in Menopause Transition. An Observational, Cross-sectional Study

August 20, 2026 updated by: Rossella Nappi, Fondazione IRCCS Policlinico San Matteo di Pavia

The goal of this observational study is to investigate the prevalence of autoimmune or immune-mediated conditions in women during the menopausal transition (aged 40-60 years). The main questions it aims to answer are:

  • What is the prevalence of autoimmune or immune-mediated conditions in women aged 40-60 years across different reproductive stages?
  • How do inflammatory markers, resilience, lifestyle factors, and allostatic load scores relate to menopause-related symptoms and general health?

Participants will complete evaluations, provide samples for clinical, immunological, and biochemical markers, and undergo assessments to analyze symptom burden and psychosocial determinants during the menopausal transition.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women referred to the menopause clinic for the management of climacteric symptoms, perimenopausal menstrual irregularities, and/or the prevention of menopause-associated conditions, alongside women referred to an internal medicine outpatient clinic dedicated to the diagnosis and treatment of immune-mediated gastrointestinal diseases

Description

Inclusion Criteria:

  • women aged 40-60 years referred to the menopause and gastroenterological outpatient clinic

Exclusion Criteria:

  • inability to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of autoimmune or immune-mediated conditions during the menopausal transition
Time Frame: At the baseline visit (cross-sectional assessment)
At the baseline visit (cross-sectional assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INAMEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe