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Spinal Cord InjuryPhase 2/3TRT-SCINCT07742553

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

A Phase 2/3 study testing testosterone cypionate and finasteride in people with Spinal Cord Injury and Spinal Cord Injuries, run by VA Office of Research and Development at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
testosterone cypionate and finasteride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
4 sitesUnited States
Study dates
1 Oct 2027to 31 Mar 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)
  • Poorly controlled arrhythmia of any type
  • Severe valvular heart disease
  • Baseline electrocardiogram findings such as left bundle branch block or marked abnormality that precludes serial screening for occult ischemic events
  • History of unprovoked deep venous thrombosis, unprovoked pulmonary embolism, history of recurrent deep venous thrombosis or known thrombophilia
  • Major non-cardiovascular surgery (e.g., major abdominal or thoracic procedure) within 90 days before screening or a major surgery scheduled at the time of screening
  • Liver enzymes (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >1.5 times the normal upper limit
  • Severe or end-stage chronic kidney disease defined as eGFR <30 milliliters/minute (mL/min)
  • Diagnosed, but untreated severe obstructive sleep apnea
  • Use of an agent that alters sex-steroid metabolism in the past 90 days, such as: testosterone therapy (TRT), compounded or over-the-counter androgenic hormone or androgen precursor, 5-alpha reductase (5AR) inhibitors, growth hormone, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or others
  • Use of anti-resorptive or bone anabolic drug therapy in the past 180 days
  • Acute use (>5 days) of any opioid (e.g., oxycodone, hydrocodone) or systemic glucocorticoids >7.5 milligrams (mg)/day prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) in the week before screening, except for men who are taking these for a chronic condition and who are anticipated to continue these for the study duration
  • Known allergy to any TRT component (e.g., cottonseed oil or other)
  • Any other condition, lab abnormality, therapy, medical or psychiatric condition, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive a study intervention, or interfere with their ability to participate for the full study duration

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Joshua F Yarrow, PhD MS BS contact

(720) 857-5520

joshua.yarrow@va.gov

United States4 sites

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Joshua F Yarrow, PhD MS BS, (720) 857-5520, joshua.yarrow@va.gov

    Joshua F Yarrow, PhD MS BS

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135

    Dana Otzel, PhD, Dana.Otzel@va.gov

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612

    Kevin White, MD, Kevin.White2@va.gov

    Brittany Durant, RN, Brittany.Durant@va.gov

  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468-3904

    Christopher Cardozo, MD, Christopher.Cardozo@va.gov

Other trials in United States

About this study

Official title: A Multisite, Double-blind, Randomized Controlled Trial Comparing Body Composition, Muscle, and Bone Changes to TestosteRone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI 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.

Read the detailed description

There is no known cure for spinal cord injury (SCI) nor for the muscle, bone, or metabolic deficits that impair physical function, increase fracture risk, and worsen health after SCI. These deficits are preceded by the neural insult and impaired motor function and may be impacted by low testosterone, present in many men with SCI. Testosterone therapy (TRT) is known to improve musculoskeletal health, body composition, and physical function in older men with low testosterone who do not have SCI and some of the effects of TRT are known to be mediated by the 5-alpha reductase type II (5AR2) enzyme, which converts testosterone to dihydrotestosterone (DHT; a more potent endogenous metabolite). However, it remains unknown whether TRT improves muscle mass, muscle function, bone mineral density, and body composition / metabolic health in men with low testosterone and ambulatory dysfunction after chronic incomplete SCI, and whether actions of 5AR2 mediates any of the effects of testosterone in the impaired lower limbs and in other tissues with reduced neural input after SCI.

For this study, men with low testosterone and ambulatory dysfunction after chronic motor incomplete SCI will be randomized to receive TRT with or without the 5AR2-inhibitor finasteride or a placebo treatment for 9 months. TRT or placebo injection will be administered every other week; finasteride or placebo will be administered daily. Participants will be assessed at study entry and regularly thereafter. Assessments will include measurements of body composition and bone mineral density by dual energy x-ray absorptiometry (DXA) scans, bone microstructure and strength by high-resolution peripheral quantitative computerized tomography (HR-pQCT) scans, and tests of muscle strength and physical function. Participants will also undergo safety tests, including electrocardiogram (ECG) for cardiac electrophysiology, questionnaires of health status, and blood tests to assess prostate specific antigen (PSA), hematocrit, liver enzymes (AST and ALT), blood lipids, sex hormones, and other markers of health.

Being tested
testosterone cypionate, finasteride, placebo injection, placebo pill
Keywords
Testosterone, Testosterone cypionate, Testosterone enanthate, Testosterone 17 beta-cypionate, Testosterone undecanoate, Methyltestosterone, Testosterone propionate, Dihydrotestosterone, Androgens, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiologic Effects of Drugs, Pharmacologic Actions, Therapeutic Uses, Anabolic Agents, Testosterone Therapy, Testosterone Replacement Therapy, Dual Energy X ray Absorptiometry, Lean Tissue Mass, Body Composition
Medical subject headings
Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Spinal Cord Compression, Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • testosterone cypionateDrug

    Also called depo-testosterone

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

  • finasterideDrug

    Also called proscar

    Participants receive finasteride (5 mg/day) orally

  • placebo injectionDrug

    Also called inactive substance

    Participants receive placebo (weekly) by intramuscular injection

  • placebo pillDrug

    Also called inactive substance

    Participants receive placebo pill (daily) orally

Study groups in NCT07742553
Study groupRoleWhat they receive
testosterone, placeboExperimentalTestosterone by intramuscular injection (200 mg/q2wk) and placebo pill orally (5 mg/day)
Receives: Drug: testosterone cypionate; Drug: placebo pill
testosterone, finasterideExperimentalTestosterone by intramuscular injection (200 mg/q2wk) and a finasteride pill orally (5 mg/day)
Receives: Drug: testosterone cypionate; Drug: finasteride
placebo treatmentPlacebo comparatorPlacebo by intramuscular injection (q2wk) and a placebo pill orally (daily)
Receives: Drug: placebo injection; Drug: placebo pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lower limb fat-free mass

    Change from baseline in lower limb fat-free mass assessed via dual-energy X-ray absorptiometry (DXA)

    Measured: Baseline, 9 months

Secondary outcomes (5)

  1. Change in total body fat-free mass

    Change from baseline in total body fat-free mass assessed via dual-energy X-ray absorptiometry (DXA)

    Measured: Baseline, 9 months

  2. Change in knee extensor strength

    Change from baseline in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry

    Measured: Baseline, 9 months

  3. Change in distal femur bone mineral density

    Change from baseline in distal femur areal bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry

    Measured: Baseline, 9 months

  4. Change in visceral adipose tissue (fat) mass

    Change from baseline in visceral adipose tissue (fat) mass assessed via dual-energy X-ray absorptiometry

    Measured: Baseline, 9 months

  5. Change in prostate specific antigen (PSA)

    Change from baseline n prostate specific antigen (PSA) assessed in the circulation

    Measured: Baseline, 3 months, 6 months, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start1 Oct 2027 (estimated)
  3. Primary completion30 Sep 2031 (estimated)
  4. Study completion31 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group, double blind, placebo controlled randomized clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742553
Sponsor's protocol ID
RRDA-011-25W
Other IDs
1I01RD002003-01A1
Acronym
TRT-SCI
Status last verified
Jul 2026
First submitted
28 Jul 2026
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing testosterone cypionate and finasteride in people with Spinal Cord Injury and Spinal Cord Injuries, run by VA Office of Research and Development at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joshua F Yarrow, PhD MS BS ((720) 857-5520, joshua.yarrow@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lower limb fat-free mass (time frame: Baseline, 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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