An observational study in Gender Dysphoria, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University of Wisconsin, Madison · Observational
Among 31 studies in Gender Dysphoria with a site in United States — 11 open to participants now, 13 under way, 3 of them phase 3. Gender Dysphoria · United States.
Among the 31 studies in Gender Dysphoria with a site in United States, this one is the 8th largest by planned enrollment of the 16 observational ones that give a count, is one of 4 that started in 2025, is one of 16 observational ones, reaches primary completion later than 8 of the 12 other live ones, and was the 30th registered.
85 studies on the registry are indexed under Gender Dysphoria; 38 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 52 observational studies indexed under Gender Dysphoria.
Browse Gender Dysphoria studies →11 of the 31 studies in Gender Dysphoria with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 31 Gender Dysphoria studies recruiting now, 15 (48%) set no upper age limit and 10 (32%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2025.
Median enrollment 50 across the 15 interventional studies, 46 across the 16 observational. Of the 16 that completed or were terminated, 4 (25%) have results posted.
None of the 31 has an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 3 studies filed under Gender Dysphoria — fewer than ten, so there is no comparison to draw.
2 of the studies in Gender Dysphoria with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07412509University of ChicagoCan 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty? | 2027-03 |
| NCT07286123University Hospitals Cleveland Medical CenterGender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™) | 2027-06-30 |
Among the 31 studies in Gender Dysphoria with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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
Aim 2: To identify if transgender adults will demonstrate significant changes in:
Aim 3: To identify if neurocognitive function changes in transgender adults.
The investigators hypothesize that:
Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Magnetic Resonance Imaging · Other: Cognition and Health Tests · Other: Optional Exercise Test
Device: Magnetic Resonance Imaging · Other: Cognition and Health Tests · Other: Optional Exercise Test
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.
Also known as: MRI
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 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.
Change Cerebral Blood Flow (CBF)
CBF at rest and in response to cognitive stressors.
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Brain Structure
Grey matter and White matter volumes.
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Brain Connectivity
Measured using MRI.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change Cerebral Blood Flow (CBF)
Changes in CBF in response to inhaled mixture of room air and CO2
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
Dual-energy X-ray absorptiometry (DEXA)
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Blood Glucose
Glucose is a marker of metabolic health
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Insulin
Insulin is a marker of metabolic health.
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cytokines
Cytokines are a marker of inflammation.
Time frame: 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.
Time frame: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Apr 2028, 30 months after the start.
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University of Wisconsin, Madison →