Testosterone Therapy for Spinal Cord Injury
(TRT-SCI Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Who Is on the Research Team?
Joshua F Yarrow, PhD MS BS
Principal Investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
Are You a Good Fit for This Trial?
This trial is for men with chronic spinal cord injury who have low testosterone and trouble walking. Participants should not have conditions that would make testosterone therapy unsafe, such as certain cancers or severe heart, liver, or kidney problems.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Finasteride
- Placebo Injection
- Placebo Pill
- Testosterone Cypionate
Trial Overview
The study tests if testosterone therapy alone or combined with finasteride (which blocks a hormone related to prostate growth) helps improve muscle, bone health, and body fat in men with spinal cord injury. Some participants will get placebo injections or pills for comparison.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Testosterone by intramuscular injection (200 mg/q2wk) and placebo pill orally (5 mg/day)
Testosterone by intramuscular injection (200 mg/q2wk) and a finasteride pill orally (5 mg/day)
Placebo by intramuscular injection (q2wk) and a placebo pill orally (daily)
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
VA Eastern Colorado Health Care System
Collaborator
University of Colorado, Denver
Collaborator
North Florida/South Georgia Veterans Health System
Collaborator
James J. Peters Veterans Affairs Medical Center
Collaborator
James A. Haley Veterans Administration Hospital
Collaborator
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