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Can HRT protect against colds and flu in menopause? new study investigates

NCT ID NCT07292857

Knowledge-focused Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study follows 400 women aged 40-60 to compare respiratory infection rates between those taking hormone replacement therapy (HRT) and those not. Participants wear a smartwatch to track vital signs and report symptoms for six months. The goal is to understand if HRT influences infection risk and to develop a wearable-based early warning system for respiratory infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify whether HRT lowers or raises the risk of respiratory infections in menopausal women and lead to a wearable early-warning system for infections.
What could go wrong
This is an observational study, not a treatment trial, so it cannot prove cause and effect. Results may not apply to all women, and the wearable prediction model may not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study targets post-menopausal women aged 40-60 years, recruited from the University Hospital (Inselspital Bern), affiliated clinics, and the general public in Switzerland. Participants will be assigned to two observational cohorts based on their use of hormone replacement therapy (HRT vs. no HRT).

Ages

40 to 60 years

Sex

Female participants only

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Biological sex: female * Age: 40-60 years * Self-determined decision to participate, confirmed by signing the informed consent form (ICF) * Fluent in German * Agreement to wear a smartwatch (Garmin Vivosmart 5) for most of the time over six months * Ownership of a smartphone compatible with the Fitrockr application * Confirmed post-menopausal status: Spontaneous amenorrhea for ≥12 consecutive months without other causes OR ≥6 months of spontaneous amenorrhea with biochemical confirmation (FSH \> 40 IU/L OR FSH \> 30 IU/L for women aged ≥50 using hormonal contraception) OR bilateral oophorectomy ≥6 weeks before enrollment Exclusion Criteria: * Inability to provide informed consent * Known allergic reaction to polycarbonate (smartwatch wristband material) * Asthma not well-controlled (ACT score \<20 despite medication) * Use of injectable asthma drugs with broad immunomodulatory activity * Coronary artery disease * Diagnosis of diabetes mellitus * Cancer diagnosis * Diagnosis of chronic kidney disease * Confirmed diagnosis of familial hypercholesterolemia (genetic) * Sleep apnea managed with bi-level positive airway pressure (PAP) * Chronic rhinosinusitis * Severe (stage 3 or 4) chronic obstructive pulmonary disease (COPD) or interstitial lung disease with hospitalization within the prior 12 months for respiratory symptoms * Any other condition/treatment deemed incompatible with the study objectives by the PI or delegated co-investigators * Current employment in the Section of Gynecological Endocrinology and Reproductive Medicine (Inselspital Bern) or any other relation to the principal investigator * Concurrent participation in a clinical interventional study * Technical inability to pair the participant's smartphone with the smartwatch * Inability to comply with study procedures (e.g., due to language, psychiatric illness, or inability to attend study site)

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Menopausal women Respiratory tract infections (RTI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

    RECRUITING

    Bern, 3010, Switzerland

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Other studies related to the condition(s) this trial covers.