Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial

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.

NCT Number	NCT07742553
Lead Sponsor	VA Office of Research and Development Collaborators: North Florida/South Georgia Veterans Health System, VA Eastern Colorado Health Care System, University of Colorado, Denver, James J. Peters Veterans Affairs Medical Center, James A. Haley Veterans Administration Hospital
Conditions	Spinal Cord Injury, Spinal Cord Injuries, Injuries, Spinal Cord, Spinal Cord Contusion, Spinal Cord Trauma, Trauma, Nervous System, Wounds and Injuries, Spinal Cord Compression +6 more
Enrollment	300 participants
Start Date	2027-10-01
Primary Completion	2031-09-30 (estimated)
Study Completion	2032-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-04