Testosterone Plus Finasteride Treatment After Spinal Cord Injury

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