Gender DysphoriaNCT07624747
Brain Health in Transgender Adults
An observational study of Gender Dysphoria, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- Magnetic Resonance Imaging, Cognition and Health Tests and Optional Exercise Test
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
Who may be able to join
- intention to undergo GAHT
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Cerebral Blood Flow and Neurocognitive Performance in Adults Undergoing Gender-affirming Hormone Therapy
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.
Read the detailed description
The purpose of this study is to assess the effects of GAHT on cerebral structure and function. To this end, this study has three aims:
Aim 1: To identify if transgender males and females demonstrate changes in
- A) basal CBF and
- B) CBF responses to acute stress-particularly in areas involved in cognition, memory, and learning.
Aim 2: To identify if transgender adults will demonstrate significant changes in:
- A) overall brain structure,
- B) functional connectivity, and
- C) task activation.
Aim 3: To identify if neurocognitive function changes in transgender adults.
The investigators hypothesize that:
- Aim 1: Transgender females will demonstrate increased basal CBF and larger CBF responses to acute stress, particularly in areas involved in cognition, memory, and learning, whereas transgender males will display lower basal CBF and lower CBF responses to acute stress.
- Aim 2: Transgender patients will demonstrate significant changes in: a) overall brain structure, b) functional connectivity, and c) task activation.
- Aim 3: Neurocognitive function will increase in transgender females and decreases in transgender males, primarily in the domains of memory, attention, executive function, and processing speed.
- Conditions
- Gender Dysphoria
- Being tested
- Magnetic Resonance Imaging, Cognition and Health Tests, Optional Exercise Test
- Keywords
- Gender-Affirming Hormone Therapy, brain health
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Also called MRI
Two MRI visits (baseline and after 4-6 months of continuous GAHT) will involve structural scans of the brain, scans while performing cognitive tasks, and a scan taken while responding to an inhaled CO2 stressor. This visit will take approximately 1.5 hours.
Cognition and Health TestsOther
Two cognition and health test trials (baseline and after 4-6 months of continuous GAHT) will involve a body composition scan to determine body fat percentage, muscle mass, and bone density. This will be followed by a set of cognitive tasks using the NIH Toolbox.
Optional Exercise TestOther
Optional graded exercise test will be performed if the participant consents to this optional procedure (baseline and after 4-6months of continuous GAHT). to determine cardiorespiratory fitness. This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry.
| Study group | Role | What they receive |
|---|---|---|
| Male at birth undergoing GAHT with their Clinical Care Team | Not described Receives: Device: Magnetic Resonance Imaging; Other: Cognition and Health Tests; Other: Optional Exercise Test | |
| Female at birth undergoing GAHT with their Clinical Care Team | Not described Receives: Device: Magnetic Resonance Imaging; Other: Cognition and Health Tests; Other: Optional Exercise Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Cerebral Blood Flow (CBF)
CBF at rest and in response to cognitive stressors.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Brain Structure
Grey matter and White matter volumes.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Brain Connectivity
Measured using MRI.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Flanker Inhibitory Control and Attention
NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Pattern Comparison Processing Speed Test
NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: List Sorting Working Memory Test
NIH Toolbox to assess neurocognitive function. The List Sorting Working Memory Test is a measure of recall and sorting. Participants scores reflect the number of items recalled and appropriately sorted up to 28 items maximum.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Dimensional Change Card Sort Test
NIH Toolbox to assess neurocognitive function. The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Picture Vocabulary Test
NIH Toolbox to assess neurocognitive function. The Picture Vocabulary Test has the participant hear a word and then pick from one of four pictures that best represents the word. It is scored using a T-score where 100 is the average, higher scores indicate better performance.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Secondary outcomes (7)
Change Cerebral Blood Flow (CBF)
Changes in CBF in response to inhaled mixture of room air and CO2
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Changes in sex steroid concentrations
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Body Composition
Dual-energy X-ray absorptiometry (DEXA)
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Blood Glucose
Glucose is a marker of metabolic health
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Insulin
Insulin is a marker of metabolic health.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cytokines
Cytokines are a marker of inflammation.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Optional Graded Exercise Test: VO2 Max
An optional graded exercise test will be performed to determine cardiorespiratory fitness. This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry. This will be a ramped exercise test, starting at a wattage of 50W and increasing in difficulty by 1 watt every 2 seconds. The purpose of this is to begin at a low intensity and gradually increase the difficulty until exhaustion is reached.
Measured: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start14 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Schrage, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624747
- Sponsor's protocol ID
- 2024-1861
- Other IDs
- Protocol Version 1/12/26, SOE/Kinesiology
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow and Neurocognitive Performance in Adults Undergoing Gender-affirming Hormone Therapy
- ClinicalTrials.gov ID
- NCT07624747
- Acronym / sponsor ID
- 2024-1861
- Conditions
- Gender Dysphoria
- Keywords
- Gender-Affirming Hormone Therapy, brain health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to assess the effects of GAHT on cerebral structure and function. To this end, this study has three aims:
Aim 1: To identify if transgender males and females demonstrate changes in
- A) basal CBF and
- B) CBF responses to acute stress-particularly in areas involved in cognition, memory, and learning.
Aim 2: To identify if transgender adults will demonstrate significant changes in:
- A) overall brain structure,
- B) functional connectivity, and
- C) task activation.
Aim 3: To identify if neurocognitive function changes in transgender adults.
The investigators hypothesize that:
- Aim 1: Transgender females will demonstrate increased basal CBF and larger CBF responses to acute stress, particularly in areas involved in cognition, memory, and learning, whereas transgender males will display lower basal CBF and lower CBF responses to acute stress.
- Aim 2: Transgender patients will demonstrate significant changes in: a) overall brain structure, b) functional connectivity, and c) task activation.
- Aim 3: Neurocognitive function will increase in transgender females and decreases in transgender males, primarily in the domains of memory, attention, executive function, and processing speed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male at birth undergoing GAHT with their Clinical Care Team | – | Device: Magnetic Resonance Imaging, Other: Cognition and Health Tests, Other: Optional Exercise Test |
| Female at birth undergoing GAHT with their Clinical Care Team | – | Device: Magnetic Resonance Imaging, Other: Cognition and Health Tests, Other: Optional Exercise Test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
Key inclusion criteria (1 listed)
- intention to undergo GAHT
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRITwo MRI visits (baseline and after 4-6 months of continuous GAHT) will involve structural scans of the brain, scans while performing cognitive tasks, and a scan taken while responding to an inhaled CO2 stressor. This visit will take approximately 1.5 hours. | Device | Female at birth undergoing GAHT with their Clinical Care Team, Male at birth undergoing GAHT with their Clinical Care Team |
| Cognition and Health TestsTwo cognition and health test trials (baseline and after 4-6 months of continuous GAHT) will involve a body composition scan to determine body fat percentage, muscle mass, and bone density. This will be followed by a set of cognitive tasks using the NIH Toolbox. | Other | Female at birth undergoing GAHT with their Clinical Care Team, Male at birth undergoing GAHT with their Clinical Care Team |
| Optional Exercise TestOptional graded exercise test will be performed if the participant consents to this optional procedure (baseline and after 4-6months of continuous GAHT). to determine cardiorespiratory fitness. This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry. | Other | Female at birth undergoing GAHT with their Clinical Care Team, Male at birth undergoing GAHT with their Clinical Care Team |
Primary outcome
Change Cerebral Blood Flow (CBF)
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
CBF at rest and in response to cognitive stressors.
Change in Brain Structure
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Grey matter and White matter volumes.
Change in Brain Connectivity
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Measured using MRI.
Change in Cognitive Function: Flanker Inhibitory Control and Attention
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.
Change in Cognitive Function: Pattern Comparison Processing Speed Test
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items.
Change in Cognitive Function: List Sorting Working Memory Test
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The List Sorting Working Memory Test is a measure of recall and sorting. Participants scores reflect the number of items recalled and appropriately sorted up to 28 items maximum.
Change in Cognitive Function: Dimensional Change Card Sort Test
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40.
Change in Cognitive Function: Picture Vocabulary Test
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Picture Vocabulary Test has the participant hear a word and then pick from one of four pictures that best represents the word. It is scored using a T-score where 100 is the average, higher scores indicate better performance.
7 secondary outcomes
Change Cerebral Blood Flow (CBF)
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Changes in sex steroid concentrations
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Body Composition
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Blood Glucose
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Insulin
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cytokines
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Optional Graded Exercise Test: VO2 Max
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Schrage, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shawn Bolin, MS (608-263-6308, sbolin@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Cerebral Blood Flow (CBF) (time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.