Testosterone Therapy for Spinal Cord Injury

(TRT-SCI Trial)

Not yet recruiting at 3 trial locations
JF
Overseen ByJoshua F Yarrow, PhD MS BS
Age: 18+
Sex: Male
Trial Phase: Phase 2 & 3
Sponsor: VA Office of Research and Development
Prior Safety DataThis treatment has passed at least one previous human 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?

JF

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

Veterans eligible for care within the Veterans Health Administration (VHA)
Low total testosterone (<300 nanograms/deciliter [ng/dL]) and/or low free testosterone (<4.6 ng/dL)
Medically stable condition asymptomatic for bladder infection, major decubiti, cardiopulmonary disease, or other significant condition interfering with study
See 4 more

Exclusion Criteria

I have a heart rhythm problem that is not well controlled.
Involvement in another research study that may influence outcomes
I have had prostate or breast cancer in the past.
See 27 more

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

Group I: testosterone, placeboExperimental Treatment2 Interventions
Group II: testosterone, finasterideExperimental Treatment2 Interventions
Group III: placebo treatmentPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

VA Eastern Colorado Health Care System

Collaborator

Trials
55
Recruited
26,200+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

North Florida/South Georgia Veterans Health System

Collaborator

Trials
8
Recruited
2,000+

James J. Peters Veterans Affairs Medical Center

Collaborator

Trials
59
Recruited
2,900+

James A. Haley Veterans Administration Hospital

Collaborator

Trials
21
Recruited
13,200+