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New study tracks pain changes in gender minority adults on hormone therapy

NCT ID NCT06939257

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 50 years

Sex

Anyone

Healthy volunteers

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

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.

Pain

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.