Testosterone Plus Finasteride Treatment After Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    May 1, 2022
  • participants needed
    30
  • sponsor
    VA Office of Research and Development
Updated on 15 March 2021
testosterone
testosterone level
finasteride
spinal cord
bone mineral density
spinal cord disorder
spinal disease
pressure ulcer
incomplete spinal cord injury
cardiopulmonary disease
decubitus ulcer

Summary

The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.

Description

Men with spinal cord injury (SCI) experience a high prevalence of hypogonadism which influences the neural, muscular, skeletal, and body composition deficits that occur after injury. It remains unknown whether testosterone administration improves bone mineral density, muscle mass and muscle function, and body composition / metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. In addition, it is unknown whether testosterone or the 5-alpha reduced metabolite dihydrotestosterone (an endogenous metabolite of testosterone) mediate effects in these and other tissues.

For this study hypogonadal men with motor incomplete spinal cord injury who present with ambulatory dysfunction will be randomized to receive testosterone plus the 5-alpha reductase inhibitor finasteride or a placebo treatment for 12 months. Testosterone or placebo injection will be administered weekly; finasteride or placebo will be administered daily. Participants will be assessed at study entry and at 1-6 month intervals thereafter. Assessments will include measurements such as a dual energy x-ray absorptiometry (DEXA) scan, MRI scan, and muscle performance tests. Participants will also have several safety tests, including electrocardiogram (EKG) for cardiac electrophysiology, prostate digital rectal exam and prostate ultrasound sizing for prostate health, and blood tests to assess hematocrit, liver enzymes (AST and ALT), prostate specific antigen (PSA), cholesterol, and other health markers.

Details
Condition Endocrine disorder, CNS disorder, Spinal Cord Injury, Myelopathy, Spinal Cord, Neurological injury, Trauma, Hypogonadism, Male genital organ disease NOS, nervous system disorder, Gonadal Disorders, Spinal Cord Injuries, Wounds, Spinal Cord Disorders, Neurologic Disorders, spinal cord disease, gonadal dysfunction, neurological disorders, neurological disorder, neurologic disorder, disorders of the nervous system, nervous system disease, neurological disease, nervous system disorders, cns disease, diseases of the central nervous system, central nervous system disorders, central nervous system disease, disorder central nervous system, endocrinopathy, endocrine disorders, endocrine disease, endocrine diseases, spinal cord diseases, spinal cord disorder, myelopathies
Treatment Placebo, testosterone enanthate, finasteride
Clinical Study IdentifierNCT02248701
SponsorVA Office of Research and Development
Last Modified on15 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Hypogonadism or Neurologic Disorders or Neurological injury or Spinal Cord Injuries or Myelopathy or Spinal Cord Injury or Endocrine disorder or Wound...?
Do you have any of these conditions: nervous system disorder or Wounds or diseases of the central nervous system or spinal cord disease or nervous system disorders or neurological disorde...?
Do you have any of these conditions: diseases of the central nervous system or endocrinopathy or Wounds or Gonadal Disorders or nervous system disorders or Endocrine disorder or nervous s...?
Do you have any of these conditions: Neurological injury or Spinal Cord Injuries or nervous system disease or disorders of the nervous system or central nervous system disorders or nervou...?
Male > 18 years of age
Traumatic, vascular, or orthopedic spinal cord injury between C2-L3 >12 months prior to enrollment
Motor incomplete spinal cord (AIS C/D)
Ambulatory dysfunction
Medically stable condition that is asymptomatic for bladder infection, decubiti, cardiopulmonary disease, or other significant medical conditions
Serum total testosterone (<325 ng/dL) or bioavailable testosterone (<70 ng/dL)

Exclusion Criteria

Currently participating in another research protocol that may influence study outcomes
Life expectancy <1 year
History of or current congenital spinal cord injury or other degenerative spinal disorder
Diagnosis of multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment/injury
History of venous thromboembolism within the last 6 months, specifically deep venous thromboembolism and pulmonary embolism, history of recurrent venous thromboembolism or know hereditary thrombophilia
Poorly compensated or uncontrolled cardiovascular disease
Any major cardiovascular event within the last 12 months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, hospitalization due to unstable angina, transient ischemic attack, or stroke)
Any angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
New York Heart Association (NYHA) class III or IV congestive heart failure
Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mm Hg
Poorly controlled arrhythmia
Severe valvular disease
LDL cholesterol >160 mg/dl with known history of any major cardiovascular event, as defined above, within the last 12 months
Baseline EKG findings (e.g. left bundle branch block) or marked EKG abnormalities that would preclude serial screening for occult ischemic events
Current prostate, breast, or other organ cancer
History of prostate, breast, or other organ cancer, with the exceptions of completely resolved basal or squamous cell carcinoma for a duration of >24 months or completely resolved melanoma for a duration of >24 months
Serum prostate-specific antigen (PSA) >3.0 ng/ml
History of benign prostate enlargement (BPE) >40cc, evaluated via TRUS
Hematocrit >47%
Liver enzymes (AST / ALT) above normal upper limit
Creatinine >1.4 mg/dL
Serum calcium >10.5 mg/dL
Gynecomastia
Mental state that precludes understanding of the protocol
Diagnosed, but untreated moderate or severe sleep apnea
Spinal nutrition screening tool score >15
Severe claustrophobia that precludes MRI testing
Current anticoagulant therapy
Use of any of the following pharmacologic agents in the previous 3 months (testosterone, leuprolide, androgenic hormones, growth hormone, oral androgen precursors, 5-alpha reductase or aromatase inhibitors)
Use of anti-resorptive or bone anabolic drug therapy in the previous 6 months
Known allergy to sesame oil
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