RecruitingNot Applicable

Brain Health in Transgender Adults

United States72 participantsStarted 2025-10-14

Plain-language summary

The purpose of this study is to test whether and how a person's brain changes in the first few months after starting gender affirming hormone therapy (GAHT). The investigators want to know if GAHT changes: 1) cerebral blood flow (CBF), 2) brain structure, connectivity, and cognitive task performance, and 3) neurocognitive function (memory, attention, executive function, processing speed). 36 male at birth and 36 female at birth participants will conduct baseline studies prior to GAHT, with a second identical set of study visits 4-6 months after GAHT begins.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * intention to undergo GAHT Exclusion Criteria: * BMI greater than 40 kg/m2 * Age greater than 45 yrs * Blood pressure greater than 140/90 (stage II hypertension) * A current diagnosis of type II diabetes * History of traumatic brain injury/concussion, stroke, or seizures * Are post-menopausal * Previously taken hormone therapy medications * Self-reported pregnancy (no pregnancy test)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change Cerebral Blood Flow (CBF)

Timeframe: baseline and up to 6 months (after 4-6 months of continuous GAHT)

Change in Brain Structure

Timeframe: baseline and up to 6 months (after 4-6 months of continuous GAHT)

Change in Brain Connectivity

Timeframe: baseline and up to 6 months (after 4-6 months of continuous GAHT)

Change in Cognitive Function: Flanker Inhibitory Control and Attention

Timeframe: baseline and up to 6 months (after 4-6 months of continuous GAHT)

Change in Cognitive Function: Pattern Comparison Processing Speed Test

Timeframe: baseline and up to 6 months (after 4-6 months of continuous GAHT)

Change in Cognitive Function: List Sorting Working Memory Test

Timeframe: baseline and up to 6 months (after 4-6 months of continuous GAHT)

Change in Cognitive Function: Dimensional Change Card Sort Test

Trial details

NCT IDNCT07624747

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-04

Contact for this trial

Shawn Bolin, MS

608-263-6308 sbolin@wisc.edu

View on ClinicalTrials.gov More Gender Dysphoria trials