Pain Outcomes Associated With Exogenous Hormone Therapy in Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUniversity of Kansas Medical Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsSponsors and collaborators
University of Kansas Medical Center
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov