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Does estrogen rewire the teenage brain and trigger headaches?

NCT ID NCT05607303

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are observing transgender girls aged 11 to 20 who plan to start estrogen therapy, alongside cisgender boys as a comparison group. The study tracks headache frequency through daily diaries and uses MRI scans to look at the amygdala and brain connectivity. The goal is to understand whether estrogen affects headaches and brain structure during puberty.

What this could mean

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

Active substance
clinical estrogen therapy prescribed by a participant's own doctor
What this could lead to
If estrogen turns out to influence headache patterns, doctors could better anticipate and manage headaches in transgender girls starting hormone therapy. It could also clarify how sex hormones shape brain regions tied to mood and stress.
What could go wrong
This is an observational study, so it can show patterns but cannot prove that estrogen causes headaches or brain changes. Headache diaries and MRI scans capture only part of a complex picture, and the results may not apply to everyone.

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

138 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Jun 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

Study population is limited to transgender females (male sex, female gender identity) for the case population and cisgender males (male sex, male gender identity) for the purposes of the study analysis as outlined in the protocol.

Ages

9 to 20 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: For MTF youth (cases): * Identify as MTF * Age 11-20 years at the time of enrollment * Plan to start estrogen clinically in \< 6 months For cisgender male youth (controls): * Identify as cisgender male * Age 9-20 years at the time of enrollment * No diagnosis of Klinefelter Syndrome (XXY) Exclusion Criteria: * Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety * Known history of stroke, multiple sclerosis, or other serious neurologic condition * MRI-specific exclusion criteria (Weight \> 500 lbs, claustrophobia, metal in body)

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Conditions

The condition(s) this trial relates to.

Headache headache disorder

As listed by the trial registrant

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

Gender identity Headache

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

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