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Not yet recruitingNCT07784400Updated Aug 25, 2026

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

An observational study in Autoimmune Diseases and Menopause, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Not yet recruiting at 1 site in Italy. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
300
Ages
40 Years to 60 Years
Sex
Female
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Study summary

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.

02

Conditions studied

  • Autoimmune Diseases
  • Menopause

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03

In context

Autoimmune Diseases

802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.

This study's planned enrollment of 300 is close to the median of 300 across 229 observational studies indexed under Autoimmune Diseases.

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Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • inability to give consent
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

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

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Study locations

1 site
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 25, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07784400
Responsible party
Rossella Nappi (Principal Investigator, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Aug 25, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Aug 25, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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