Testosterone Plus Finasteride Treatment After Spinal Cord Injury
Condition: Spinal Cord Injury; 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
MeSH terms: Spinal Cord Injuries; Nervous System Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Trauma, Nervous System; Genital Diseases; Genital Diseases, Male; Hypogonadism; Endocrine System Diseases; Gonadal Disorders; Wounds and Injuries
Intervention: Testosterone Enanthate; Finasteride; Placebo injection; Placebo pill
Intervention description: Subjects receive testosterone (125 mg/week) by intramuscular injection; Subjects receive finasteride (5 mg/day) orally; Subjects receive placebo (weekly) by intramuscular injection; Subjects receive placebo pill (daily) orally
Intervention MeSH terms: Methyltestosterone; Finasteride; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Testosterone; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Androgens; Hormones; Hormone Substitutes, and Hormone Antagonists; Physiologic Effects of Drugs; Pharmacologic Actions; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Therapeutic Uses; Anabolic Agents; 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; Body Fat; Density, Bone; Bone Formation; Bone Resorption; Bone Density Conservation Agents; Magnetic Resonance Imaging; Muscle, Skeletal; Bone and Bones; Gait; Walking; Locomotion; Motor Activity

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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