Testosterone Plus Finasteride Treatment After Spinal Cord Injury

This is an interventional supportive care trial for Spinal Cord Injury focused on measuring 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 Read More

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