Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial (NCT07742553) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial
United States300 participantsStarted 2027-10-01
Plain-language summary
Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life. These deficits result from reduced activity after SCI and may be worsened by low testosterone, which is present in many men with SCI. In older men with low testosterone who do not have SCI, testosterone therapy (TRT) is known to increase muscle mass, muscle strength, and bone mineral density, and to reduce body fat. However, it is not known if TRT is effective in men with SCI. The purposes of this study are to determine the effectiveness of TRT in men who have low testosterone and difficulty walking after chronic motor incomplete SCI and to assess whether a process in the body that changes testosterone to dihydrotestosterone (DHT; another hormone that is stronger than testosterone) impacts the effectiveness of TRT in the impaired lower limbs and in other tissues after SCI. The researchers hypothesize that TRT will improve muscle and bone in the impaired limbs of men with chronic incomplete SCI and reduce fat mass, and that finasteride (a drug that blocks that blocks a process that changes testosterone to DHT) will influence prostate symptoms but not the musculoskeletal or body composition benefits produced by TRT.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veterans eligible for care within the Veterans Health Administration (VHA)
* Diagnosis of motor incomplete SCI (AIS C-D) for \>24-months involving spinal segment lumbar (L)1 or above from trauma, vascular, or orthopedic pathology
* Low total testosterone (\<300 nanograms/decilliter \[ng/dL\]) and/or low free testosterone (\<4.6 ng/dL)
* Presence of one or more sign of low testosterone, defined as:
* decreased energy
* motivation
* initiative or self-confidence
* increased fatigue or tiredness
* reduced sexual desire or activity
* decreased spontaneous (e.g., morning) erections or erectile dysfunction
* loss of body hair or reduced shaving
* feeling sad or blue or having a depressed mood or a persistent low-grade depressive disorder (defined as a score of \>3 on the Patient Health Questionnaire \[PHQ\]-2)
* hot flashes
* fatigue or irritability
* poor concentration or memory
* mild unexplained (normocytic-normochromic) anemia, defined as hematocrit (HCT) \<40%, hemoglobin \<13.6 grams/deciliter (g/dL), or red blood cell count \<4.5 million/microliter (mcL)
* sleep disturbances or increased sleepiness
* reduced muscle bulk, strength, or physical function
* increased body fat or body mass index
* Presence of motor impairment, defined as self-selected walking pace ≤1.0 meters/second (m/s) on a 10-meter walk test (10mWT), with or without gait devices or braces and with or without assistance from another person, or as self-selec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing testosterone therapy with or without finasteride after spinal cord injury — given that it's a Phase 2/3 study, what do we already know about the safety of combining testosterone and finasteride in people with spinal cord injuries, and what's still uncertain?
2The trial's main goal is measuring changes in lower limb fat-free mass — how would that outcome actually matter for my specific level and type of spinal cord injury, and is that a meaningful goal for my recovery?
3Since the trial isn't recruiting yet, how long might it realistically be before I could even enroll, and is waiting the right move given where I am in my recovery right now?
4Finasteride is sometimes used to reduce side effects of testosterone therapy — is there a reason my doctor might prefer me to be in the group that receives both medications versus testosterone alone, based on my current health?
5Are there standard treatments for the low testosterone or muscle loss that can happen after spinal cord injury that I should consider now, rather than waiting for this trial to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.