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Hormone Therapy's hidden heart effects under the microscope

NCT ID NCT06245681

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how gender-affirming hormone therapy with testosterone or estrogen changes heart function, fat in the liver and heart, and insulin sensitivity. Researchers will follow 40 transgender adults (20 male-to-female, 20 female-to-male) for 6 months using MRI scans and glucose tests. The goal is to better understand the cardiovascular risks and benefits of these hormones.

What this could mean

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

Active substance
gender-affirming hormone therapy (testosterone or estrogen)
What this could lead to
If successful, this study could clarify how sex hormones influence heart health and fat distribution, potentially guiding safer hormone therapy for transgender individuals.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to everyone. It observes changes but does not test a new treatment, so no direct health benefits are expected.

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 40 people

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

Started

Oct 2017

Expected to finish

Oct 2028

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

healthy transgender persons undergoing gender-affirming hormone therapy (either testosterone or estrogen-based hormone therapy

Ages

18 to 99 years

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: * DSM-IV diagnosis of Gender Identity Disorder * age over 18 years Exclusion Criteria: * age under 18 years severe neurological or internal diseases * steroid hormone treatment within 2 months prior to inclusion (including birth control pill, phytohormones) * treatment with psychotropic agents such as SSRIs * any implant or stainless-steel graft * abnormal values in routine laboratory screening or general physical examination * current substance abuse (determined using drug screening at the screening visit) * pregnancy (determined at screening visit and first MRI scan) * failure to comply with the study protocol or to follow the instructions of the investigating

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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

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

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