Hormone replacement therapy and respiratory infection risk in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort that follows postmenopausal women aged 40–60 to compare rates and severity of respiratory tract infections between those using hormone replacement therapy (HRT) and those not using HRT. Participants will wear a Garmin Vivosmart 5 and use a compatible smartphone app (Fitrockr) for most days over a six-month period to collect physiological and activity data, alongside clinical and questionnaire information. The study excludes people with major comorbidities such as uncontrolled asthma, diabetes, coronary artery disease, or active cancer to reduce confounding. Collected data will be used to compare outcomes by HRT status and to build predictive models of RTI risk.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Petra Stute, Prof. Dr. med. — Department of Obstetrics and Gynecology, University Hospital of Bern
• Study coordinator: Petra Stute, Prof. Dr. med.
• Email: petra.stute@insel.ch
• Phone: +41 31 632 1010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.