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Does testosterone reshape the teen brain and ease headaches?

NCT ID NCT06670053

NEW Knowledge-focused Sponsor: University of Colorado, Denver 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are studying how testosterone therapy affects headaches and brain structure in transmasculine teens. About 100 participants aged 12 to 20 who plan to start testosterone will have brain MRI scans, blood tests, and headache diaries over one year. The goal is to learn whether the hormone changes headache patterns or brain regions involved in pain.

What this could mean

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

Active substance
testosterone hormone therapy
What this could lead to
If researchers find a link between testosterone and headache or brain changes, it could help doctors better predict and manage headaches in transmasculine teens starting hormone therapy.
What could go wrong
This is an observational study of 100 teens, so it can show patterns but cannot prove testosterone causes any change. Headache and brain MRI results may vary widely, and findings may not apply to other groups.

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 100 people

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

Started

Dec 2024

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

transmasculine and gender diverse youth

Ages

12 to 20 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: 1. transmasculine and gender diverse 2. assigned female at birth 3. age 12-20 years at the time of enrollment 4. plan to start testosterone clinically in \< 6 months 5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment Exclusion Criteria: 1. cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures 2. known history of stroke, multiple sclerosis, or other serious neurologic condition 3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development 4. prior diagnosis of polycystic ovarian syndrome (PCOS) 5. uncontrolled or untreated hypothyroidism 6. MRI-specific exclusion criteria: (Weight \> 500 lbs, severe claustrophobia, certain type of metal in body)

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Conditions

The condition(s) this trial relates to.

Headache headache disorder migraine disorder

As listed by the trial registrant

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

Gender dysphoria in adolescents and adults Gender identity Headache Transgender

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

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

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