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Can hormone therapy change liver health? a new study investigates

NCT ID NCT07746999

Knowledge-focused Sponsor: Corey DeStefano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study looks at liver health in transgender people who are on gender-affirming hormone therapy (GAHT). It compares those who have been on hormones for more than six months with those on them for less time. Researchers will measure liver function through blood tests and a special scan called FibroScan to check for fat buildup or stiffness. The goal is to see if hormone therapy is linked to any liver issues and to understand other risk factors like weight and alcohol use.

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 (GAHT)
What this could lead to
If this study finds that hormone therapy affects liver health, it could lead to better monitoring and safer hormone regimens for transgender individuals.
What could go wrong
This is an observational study with a small number of participants, so it may not capture all factors or apply to everyone. It will not prove that hormones cause liver changes.

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 60 people

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

Started

Mar 2025

Expected to finish

Mar 2027

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

A total of 60 participants will be recruited throughout the study, with a ratio of 1:1 between transgender participants who have been on GAHT more than 6 months ( = or \> 182 days), and transgender participants who have been on GAHT for less than 6 months ( \< 181 days) at the start of the study.

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: Transgender individuals (18 years or older). Individuals who are able to write and/or read in English. - Exclusion Criteria: * Inability to provide informed consent Individuals with known decompensated liver cirrhosis.

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Conditions

The condition(s) this trial relates to.

hepatitis C virus infection liver disorder

As listed by the trial registrant

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

Hepatitis C (HCV)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)

    Newark, New Jersey, 07103, United States

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