The Impact of Gender Affirming Hormone Therapy on Pain In Gender Minority Adults

NCT06939257 | Recruiting

• 2 other identifiers: STUDY001607651R01NS135833-01A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Gender Minority Individuals

Keywords

GHT; Gender Minority; HRT; Gender Affirming Hormone Therapy; GM

Outcome Measures

Primary Outcomes (3)

• Prevalence of Chronic Pain in Gender Minority Adults Initiating GHT

  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.

  Baseline and 1, 3, 6, and 12-months.

• fMRI Changes in Functional Connectivity

  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.

  Baseline (pre-GHT) and 12-months (post-GHT)

• Qualitative Interview Outcome Measure

  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.

  Baseline (pre-GHT) and 12-month (post-GHT)

Secondary Outcomes (4)

• Severity of Chronic Pain

  Baseline and 1, 3, 6, and 12-months

• Magnitude of Nociplastic Pain

  Baseline and 1, 3, 6, and 12-months.

• Quantitative Sensory Testing within the fMRI

  Baseline (pre-GHT) and 12-months (post-GHT)

• Gray Matter Volume after initiating GHT

  Baseline (pre-GHT) and 12-months (post-GHT)

Study Arms (2)

Persons Initiating GHT

Gender Minority Persons Not Taking GHT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: All gender minority persons
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Gender minority individuals from within the greater Kansas City area

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (32)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples may be retained

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea L Chadwick, MD, MSc, FASA

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Schulze, MSc

CONTACT

913-588-7630; FACELab@kumc.edu

Miranda McMillan, MSc

CONTACT

913-588-7630; FACELab@kumc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 16, 2029
• Study Completion (Estimated): September 16, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)