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10-Year study to reveal hidden heart and metabolic risks of hormone therapy

NCT ID NCT06291675

Knowledge-focused Sponsor: Medical University of Vienna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 50 transgender men and women who have been on gender-affirming hormone therapy for 2 years. Researchers will use MRI scans, blood tests, and questionnaires to track changes in heart function, fat in the heart, liver, and pancreas, insulin system, and mental health at 2, 5, and 10 years. The goal is to understand the long-term health effects of hormone therapy, which most studies have only looked at short-term.

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 50 people

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

Started

Mar 2023

Expected to finish

Mar 2033

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

Our study aims to enroll transgender probands who took part in our pilot study. 30 transgender women and 30 transgender men will be recruited from the pool of participants in the previous pilot study (EK 1629/2017). The study will include transgender participants between 18 and 99 years of age, who have been taking gender affirming hormone therapy for the past 2 years. The study will not include a placebo group or a control group, and it will not interfere with the gender affirming hormone therapy in any way regarding composition and time course of the treatment.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * participation in our pilot study * ongoing gender affirming hormone therapy during the last 2 years * willingness and competence to sign the informed consent form. Exclusion Criteria: * age \< 18 years * non-MRI conditional implants, grafts, and/or devices * non-MRI conditional tattoos * claustrophobia * current substance abuse * pregnancy * failure to comply with the study protocol and/or not following the instructions of the study team.

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Conditions

The condition(s) this trial relates to.

Gender Dysphoria

As listed by the trial registrant

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

Gender dysphoria Hormone therapy induced morphologic change

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

  • Chiari Stoffwechselambulanz, Medical University of Vienna

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

More trials for these conditions

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