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

Conditions

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

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• testosterone cypionate — DRUG
  Participants receive testosterone (200 mg/q2wk) by intramuscular injection
• finasteride — DRUG
  Participants receive finasteride (5 mg/day) orally
• placebo injection — DRUG
  Participants receive placebo (weekly) by intramuscular injection
• placebo pill — DRUG
  Participants receive placebo pill (daily) orally

Study Details

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 Dates

First listed

Aug 3, 2026

Start date

Oct 1, 2027

Status verified

Jul 2026

Primary completion

Sep 30, 2031

Completion

Mar 31, 2032

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: testosterone, placebo
  Testosterone by intramuscular injection (200 mg/q2wk) and placebo pill orally (5 mg/day)
• Experimental: testosterone, finasteride
  Testosterone by intramuscular injection (200 mg/q2wk) and a finasteride pill orally (5 mg/day)
• Placebo Comparator: placebo treatment
  Placebo by intramuscular injection (q2wk) and a placebo pill orally (daily)

Primary Outcome Measure

Change in lower limb fat-free mass [ Time Frame: Baseline, 9 months ]

Central Contacts

• Joshua F Yarrow, PhD MS BS
  (720) 857-5520
  [email protected]

Locations (4)

Find similar trials in Aurora, CO

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