The Impact of Gender Affirming Hormone Therapy on Pain In Gender Minority Adults
University of Kansas Medical Center
200 participants
Mar 31, 2025
OBSERVATIONAL
Conditions
Summary
TRANSPIRE is an observational study of \~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews. Following recruitment and consent, participants will complete baseline survey measures and will repeat those measures at 1 months, 3 month, 6 months, and 12 months. QST measures, brain MRIs, and Qualitative Interviews will be offered to participants in cohort (1) and will be completed at baseline and 12 months.
Eligibility
Inclusion Criteria19
- 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 Criteria15
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06939257