Brain Health in Transgender Adults

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07624747
Status
Recruiting
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Conditions

  • Gender Dysphoria

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Magnetic Resonance Imaging — DEVICE
    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 Tests — OTHER
    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 Test — OTHER
    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 Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
72 participants (estimated)

Arms

  • Arm: Male at birth undergoing GAHT with their Clinical Care Team
  • Arm: Female at birth undergoing GAHT with their Clinical Care Team

Primary Outcome Measure

Change Cerebral Blood Flow (CBF) [ Time Frame: baseline and up to 6 months (after 4-6 months of continuous GAHT) ]

Central Contacts

Locations (1)

FacilityCityStateZIP
UW School of Medicine and Public HealthMadisonWisconsin53792

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UW School of Medicine and Public Health· Madison, WI

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