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Observational Study on Pain and Hormone Therapy in Gender Minority Adults

This observational study, called TRANSPIRE, is looking at how chronic pain changes over time in about 200 gender minority individuals. Some participants will be starting gender-affirming hormone therapy (GHT), which can include testosterone for masculinizing therapy or estrogen and progesterone for feminizing therapy. Other participants will be gender minority individuals who are not using GHT. The study aims to understand how pain is affected by GHT through surveys, quantitative sensory testing (QST - a way to measure how sensitive you are to different sensations), brain MRIs, and interviews. You might be able to join if you are between 18 and 50 years old, speak English, and are a gender minority person who is either starting GHT or not using GHT.

Study design
This is an observational study involving about 200 participants. It does not involve a specific intervention or drug being tested.
What's involved
Participants will complete surveys at baseline and then at 1, 3, 6, and 12 months. Some participants will also have QST measures, brain MRIs, and interviews at baseline and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with assessments at 1, 3, 6, and 12 months after baseline.

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NCT06939257

Pain Outcomes Associated With Exogenous Hormone Therapy in Adults

Recruiting
Not specifiedAges 18–50Observational
University of Kansas Medical Center
~200 participants
Updated 2026-05-14 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of Chronic Pain in Gender Minority Adults Initiating GHT
Measured over Baseline and 1, 3, 6, and 12-months.
+2 more outcomes measured

Conditions

Pain
Gender Minority Individuals

Explore related trials

Gender incongruencePain

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Andrea L Chadwick, MD, MSc, FASA · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Emily Schulze, MSc
[email protected]
913-588-7630
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
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

Exclusion

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

What this trial measures

  • Prevalence of Chronic Pain in Gender Minority Adults Initiating GHTBaseline and 1, 3, 6, and 12-months.

    The primary outcome is to measure the presence of chronic pain before and after the initiation of GHT. Participants will be asked if they have had pain on more than half the days of the last 3 months.

  • fMRI Changes in Functional ConnectivityBaseline (pre-GHT) and 12-months (post-GHT)

    For Aim 2 (QST and MRI), the primary outcome is to identify changes in resting state functional connectivity (e.g., ACC - PAG) over time with GHT in GM persons on masculinizing GHT and GM persons on feminizing GHT.

  • Qualitative Interview Outcome MeasureBaseline (pre-GHT) and 12-month (post-GHT)

    1\) To better understand the relationship between stress, loneliness, medical mistrust, affirmation treatment, chronic pain, and psychological functioning in GM persons. 2) To better understand the lived experiences of GM persons with and without chronic pain. 3) To better understand the lived experiences of GM persons and how gender-affirming care has impacted their overall physical and mental wellbeing.