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NCT Number: NCT07784400

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

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.

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Key information

Conditions

Autoimmune Diseases Immune System Diseases Menopause

Age range

40 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

Location contact

Rossella Nappi, MD

CONTACT

[email protected]

0382501561

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • inability to give consent

Treatment and study plan

Primary outcomes

  1. Prevalence of autoimmune or immune-mediated conditions during the menopausal transition

    Time frame: At the baseline visit (cross-sectional assessment)

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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