New study tracks pain changes in gender minority adults on hormone therapy
NCT ID NCT06939257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows about 200 gender minority adults to see if starting gender-affirming hormone therapy changes chronic pain over time. Participants fill out surveys and some also get brain scans and sensory tests. The goal is to understand how hormones, stress, and social factors affect pain and well-being.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
Gender minority individuals from within the greater Kansas City area
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Informed consent provided by the participant * Ages 18-50 years * English speaking * GM persons who have been deemed to be an appropriate medical candidate to take gender-affirming hormone therapy for gender incongruence -OR- GM persons who are not taking gender-affirming hormone therapy Aim 2 (QST and MRI) Additional Inclusion Criteria: * GM persons who have been deemed to be an appropriate medical candidate to take gender- affirming hormone therapy for gender incongruence * Stable doses of analgesic medications for at least 30 days prior to screening * Right handed * Normal visual acuity or correctable to at least 20/40 for reading instructions in the MRI * Willingness to refrain from pain medications such as NSAIDs, acetaminophen, and opioid medications for 12 hours prior to neuroimaging and QST * Willingness to refrain from alcohol and nicotine on day of QST and neuroimaging * Willingness to refrain from physical activity or exercise that would cause muscle and/or joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable) * Investigators will attempt to recruit individuals with no chronic daily use of adjunctive pain medications, including tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and gabapentinoids as these drugs can influence neuroimaging and QST findings, or have individuals be weaned off of these meds at least two weeks prior to being studied. In previous smaller imaging studies investigators could accomplish this, but this may not be possible in this large of a study. If the study team does need to allow individuals into these cohorts while on such medications because of pragmatic issues, this information will be recorded and patients will be asked to remain on a stable dose for at least two weeks prior to MRI and QST assessments. * Able to lie still on their back for 1.5 hours for MRI scans Exclusion Criteria: * Inability to provide informed consent * Age less than 18 years or greater than 50 years * Severe physical impairment (e.g., blindness, deafness, paraplegia) * Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non-skin malignancy, or autoimmune disorder) * Pregnant or nursing * Liver failure * Self-reported liver cirrhosis * Self-reported hepatitis * Severe Cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that are self-reported by patient or by medical record * Prisoner * Current litigation for chronic pain * Current disability proceedings * Active psychotic or suicidal symptoms * Current drug or alcohol use disorder * History of gonadectomy surgery Aim 2 (QST and MRI) Additional Inclusion Criteria: * Contraindications to MRI (e.g., metal implants, pacemaker, etc.) * Severe claustrophobia precluding MRI and evoked pain testing during scanning * BMI \> 40 or unable to lie comfortably in MRI * Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail) * Peripheral neuropathy * Diagnosed epilepsy or seizure history
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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