Autoimmune DiseasesNCT07784400
Inflammation, Autoimmunity and Healthy Ageing in Menopause Transition. An Observational, Cross-sectional Study
An observational study of Autoimmune Diseases and Menopause, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Autoimmune Diseases, Menopause
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Adult
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
Who may be able to join
- women aged 40-60 years referred to the menopause and gastroenterological outpatient clinic
Who cannot join
- inability to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Rossella Nappi, MD, 0382501561, r.nappi@smatteo.pv.it
About this 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.
- Conditions
- Autoimmune Diseases, Menopause
- Medical subject headings
- Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of autoimmune or immune-mediated conditions during the menopausal transition
Measured: At the baseline visit (cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossella Nappi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784400
- Sponsor's protocol ID
- INAMEN
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, Autoimmunity and Healthy Ageing in Menopause Transition. An Observational, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07784400
- Acronym / sponsor ID
- INAMEN
- Conditions
- Autoimmune Diseases, Menopause
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- women aged 40-60 years referred to the menopause and gastroenterological outpatient clinic
Key exclusion criteria (1 listed)
- inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of autoimmune or immune-mediated conditions during the menopausal transition
Time frame: At the baseline visit (cross-sectional assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Menopause, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of autoimmune or immune-mediated conditions during the menopausal transition (time frame: At the baseline visit (cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.