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Hormone therapy study could unlock secrets of immune differences

NCT ID NCT07358897

Knowledge-focused Sponsor: Imperial College London 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will follow 500 transgender adults starting gender-affirming hormone therapy to see how their immune systems change. By tracking immune cells and blood markers before and during treatment, researchers hope to understand why men and women have different rates of autoimmune diseases and infections. The goal is to learn how sex hormones alone—without the influence of chromosomes—shape immune function.

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 (estrogen or testosterone)
What this could lead to
If successful, this study could reveal how sex hormones influence immune system differences, potentially guiding new treatments for autoimmune diseases and infections.
What could go wrong
This is an observational study that does not test a treatment, so it won't directly lead to new therapies. Results may not apply to non-transgender populations.

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.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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

Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone.

Ages

18 to 50 years

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: * Adults between 18 and 50 years of age with diagnosed gender dysphoria about to start gender-affirming hormone therapy with either oestrogen or testosterone. Exclusion Criteria: * Lack of capacity to consent. * Abnormalities in expected pubertal development and pharmacological interventions that could affect levels of gonadal steroids including suspected or confirmed self-treatment with steroid hormone preparations in preceding month (birth control excluded). * Serious immunological disease (immune deficiency, autoimmune disease requiring immunomodulatory treatment). * Regular immunomodulatory treatment such as prednisolone or biological drugs. * In the case of vaccination or symptomatic infection ≤5 days before the visit blood sampling should be postponed by 1 week. * Age \<18 years or \>50 years * Completed menopause (persons assigned female sex at birth). * Positivity for blood borne viruses (HIV, Hepatitis B, Hepatitis C, HTLV-1)

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As listed by the trial registrant

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

Transgender

How to take part

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  1. 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.

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