Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial (NCT07742553)
A Multisite, Double-blind, Randomized Controlled Trial Comparing Body Composition, Muscle, and Bone Changes to TestosteRone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Rocky Mountain Regional VA Medical Center, Aurora, CO โ Aurora, Colorado
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- Rocky Mountain Regional VA Medical Center, Aurora, CO โ Aurora, Colorado
- North Florida/South Georgia Veterans Health System, Gainesville, FL โ Gainesville, Florida
- James A. Haley Veterans' Hospital, Tampa, FL โ Tampa, Florida
- James J. Peters VA Medical Center, Bronx, NY โ The Bronx, New York
๐ Contact the Study Coordinator
Phone: (720) 857-5520
Email: joshua.yarrow@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Spinal Cord Injury
- AIH-induced Walking Recovery After Subacute SCI โ Atlanta, Georgia
- C-Brace II Spinal Cord Injury โ Chicago, Illinois
- Autonomic Effects of Stimulation in SCI โ The Bronx, New York
- Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury โ Syracuse, New York
- Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury โ Cleveland, Ohio
- Electrical Stimulation for Continence After Spinal Cord Injury โ Palo Alto, California
Explore by condition: All Spinal Cord Injury clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.