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

Summary

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.

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
• Nervous System Diseases
• Spinal Cord Diseases
• Gonadal Disorders
• Endocrine System Diseases
• Hypogonadism
• Genital Diseases, Male

Interventions

DRUG

testosterone cypionate

Participants receive testosterone (200 mg/q2wk) by intramuscular injection

DRUG

finasteride

Participants receive finasteride (5 mg/day) orally

DRUG

placebo injection

Participants receive placebo (weekly) by intramuscular injection

DRUG

placebo pill

Participants receive placebo pill (daily) orally

Sponsors & Collaborators

• North Florida/South Georgia Veterans Health System

  collaborator OTHER

• VA Eastern Colorado Health Care System

  collaborator FED

• University of Colorado, Denver

  collaborator OTHER

• James J. Peters Veterans Affairs Medical Center

  collaborator FED

• James A. Haley Veterans Administration Hospital

  collaborator FED

• VA Office of Research and Development

  lead FED

Principal Investigators

• Joshua F Yarrow, PhD MS BS · Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-10-01

Primary Completion

2031-09-30

Completion

2032-03-31

FDA Drug

Yes

Countries

• United States

Study Locations