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Major study launches to track heart risks in transgender people on hormones

NCT ID NCT07187947

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study will follow 500 transgender adults who have been on gender-affirming hormone therapy for at least a year. Researchers will measure changes in blood pressure, cholesterol, body composition, and other heart health markers. The goal is to understand the long-term cardiovascular effects of hormone therapy and improve care for transgender individuals.

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 (estradiol, antiandrogens, or testosterone)
What this could lead to
If successful, this study could provide clear data on how hormone therapy affects heart health in transgender individuals, helping doctors tailor safer treatment plans.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new drug or cure. Results may take years and could still leave many questions unanswered.

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 500 people

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

Started

Jul 2025

Expected to finish

Dec 2035

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

Transgender AFAB and AMAB individuals diagnosed with gender incongruence who received medical therapy between January 2000 and December 2027 at the Gynecology and Reproductive Physiology Unit of the IRCCS AOU Bologna, Sant'Orsola University Hospital.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Diagnosis of gender incongruence * Age 18 years or older at the start of therapy * Undergoing gender-affirming (replacement or suppressive) hormone therapy with testosterone or with estradiol plus anti-androgens for at least 12 months * Provision of informed consent for study participation and for the processing of personal and sensitive data Exclusion Criteria: * Any hormone therapy received before recruitment * History of cardiovascular events prior to the initiation of hormone therapy

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Gender Dysphoria

As listed by the trial registrant

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

Cardiovascular (CV) risk Cardiovascular disease (CVD) Cardiovascular disease acute Cardiovascular disease prevention Cardiovascular disease risk factor Cardiovascular health status Gender incongruence

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

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    RECRUITING

    Bologna, BO, 40138, Italy

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