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

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Spinal Cord Injury, Spinal Cord Injuries, Injuries, Spinal Cord, Spinal Cord Contusion, Spinal Cord Trauma, Trauma, Nervous System, Wounds and Injuries, Spinal Cord Compression, Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male

In brief

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.

Key facts

Study ID

NCT07742553

Run by

VA Office of Research and Development

People needed

300

Starts

2027-10-01

Expected to finish

2032-03-31

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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-selected walking pace >1.0 m/s with reliance on a gait device or brace or with highly compensated movement impairment identified by a trained observer
• Medically stable condition asymptomatic for bladder infection, major decubiti, cardiopulmonary disease, or other significant condition that will interfere with the study
• Documented approval from a physician verifying medical status

You may not qualify if…

• Involvement in another research study that may influence outcomes
• Mental state that precludes understanding the protocol
• Life expectancy <12 months
• History of or current congenital spinal cord injury (SCI) (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate procedures
• Amyotrophic lateral sclerosis, multiple sclerosis, or other neurologic injury / impairment that may complicate procedures
• Current cancer diagnosis
• History of prostate or breast cancer
• Any diagnosed or treated cancer in the past 24 months, except basal or squamous cell carcinoma of the skin that has been successfully treated
• Any major lower-limb fracture in the past 12 months
• Unevaluated circulating prostate-specific antigen (PSA) >4.0 nanograms/milliliter (ng/mL) or >3.0 ng/mL in men with prostate cancer risk factors, including agent orange exposure, first degree relative with prostate cancer, or African American background
• Currently seeking fertility or expected during the study
• Diagnosed gynecomastia
• Hematocrit (HCT) >48%
• Any major cardiovascular event in the last 6 months, defined as:
• an acute myocardial infarction
• any cardiac revascularization procedure including stenting
• angioplasty or coronary artery bypass grafting
• revascularization of the carotid or middle cerebral artery or procedure to treat critical limb ischemia
• hospitalization due to unstable angina
• transient ischemic attack
• stroke
• peripheral vascular disease
• Any angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
• Poorly compensated congestive heart failure (New York Heart Association [NYHA] class III or IV)
• Poorly controlled hypertension when on medication (consistent systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg)

Where it is running

• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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