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

NCT07742553 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: RRDA-011-25W1I01RD002003-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Compression; Gonadal Disorders; Hypogonadism; Spinal Cord Trauma; Nervous System Diseases; Spinal Cord Diseases; Endocrine System Diseases; Genital Diseases, Male

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; Lipid and Glucose profile; Muscle Strength; 5-alpha Reductase; Muscle Mass; Bone Mineral Density; Adipose Tissue; Fat Mass; Body Fat; Density, Bone; Bone Formation; Bone Resorption; Bone Density Conservation Agents; Muscle, Skeletal; Bone and Bones; Gait; Walking; Locomotion; Motor Activity; Finasteride; Spinal Cord Injury; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Cord Injuries; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Genital Diseases, Male; Steroids

Outcome Measures

Primary Outcomes (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)

  Baseline, 9 months

Secondary Outcomes (5)

• Change in total body fat-free mass

  Baseline, 9 months

• Change in knee extensor strength

  Baseline, 9 months

• Change in distal femur bone mineral density

  Baseline, 9 months

• Change in visceral adipose tissue (fat) mass

  Baseline, 9 months

• Change in prostate specific antigen (PSA)

  Baseline, 3 months, 6 months, 9 months

Study Arms (3)

testosterone, placebo

EXPERIMENTAL

Testosterone by intramuscular injection (200 mg/q2wk) and placebo pill orally (5 mg/day)

Drug: testosterone cypionate; Drug: placebo pill

testosterone, finasteride

EXPERIMENTAL

Testosterone by intramuscular injection (200 mg/q2wk) and a finasteride pill orally (5 mg/day)

Drug: testosterone cypionate; Drug: finasteride

placebo treatment

PLACEBO COMPARATOR

Placebo by intramuscular injection (q2wk) and a placebo pill orally (daily)

Drug: placebo injection; Drug: placebo pill

Interventions

testosterone cypionate DRUG

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

Also known as: depo-testosterone

testosterone, finasteride; testosterone, placebo

finasteride DRUG

Participants receive finasteride (5 mg/day) orally

Also known as: proscar

testosterone, finasteride

placebo injection DRUG

Participants receive placebo (weekly) by intramuscular injection

Also known as: inactive substance

placebo treatment

placebo pill DRUG

Participants receive placebo pill (daily) orally

Also known as: inactive substance

placebo treatment; testosterone, placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• North Florida/South Georgia Veterans Health System: collaborator
• VA Eastern Colorado Health Care System: collaborator
• University of Colorado, Denver: collaborator
• James J. Peters Veterans Affairs Medical Center: collaborator
• James A. Haley Veterans Administration Hospital: collaborator

Study Sites (4)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

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

Gainesville, Florida, 32608-1135, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Compression; Nervous System Diseases; Spinal Cord Diseases; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Genital Diseases, Male; Bone Resorption; Motor Activity; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases

Interventions

testosterone 17 beta-cypionate; Finasteride

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Joshua F Yarrow, PhD MS BS

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua F Yarrow, PhD MS BS

CONTACT

(720) 857-5520; joshua.yarrow@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel group, double blind, placebo controlled randomized clinical trial

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): March 31, 2032
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.
• Access Criteria: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.

Locations

US (4)