Actively Recruiting
Pain Outcomes Associated With Exogenous Hormone Therapy in Adults
Led by University of Kansas Medical Center · Updated on 2026-05-14
200
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pain Outcomes Associated With Exogenous Hormone Therapy in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Aged between 18 and 50 years
- English speaking
- Gender minority persons medically approved to start gender-affirming hormone therapy or not currently using hormone therapy
- For quantitative sensory testing and MRI subgroup: stable pain medication doses for at least 30 days
- Right handed
- Normal or correctable vision to 20/40 for MRI instructions
- Willing to avoid certain pain medications, alcohol, nicotine, and strenuous exercise before testing
- Able to lie still on their back for 1.5 hours during MRI
You will not qualify if you...
- Unable to provide informed consent
- Younger than 18 or older than 50 years
- Severe physical impairments like blindness, deafness, or paralysis
- Medical conditions severely affecting physical function such as cancer or autoimmune disorders
- Pregnant or nursing
- Liver failure, cirrhosis, or hepatitis
- Severe cardiovascular diseases
- Prisoner status
- Current legal or disability claims related to chronic pain
- Active psychotic or suicidal symptoms
- Drug or alcohol use disorder
- History of gonadectomy surgery
- MRI contraindications (e.g., metal implants, pacemaker)
- Severe claustrophobia
- BMI over 40 or unable to lie comfortably in MRI
- Use of artificial nails or nail enhancements recently
- Peripheral neuropathy
- Diagnosed epilepsy or seizure history
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
E
Emily Schulze, MSc
CONTACT
M
Miranda McMillan, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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