Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Stopped early · Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT02248701
Run by: VA Office of Research and Development
People needed: 33
Starts: 2017-04-27
Expected to finish: 2021-08-13
Last updated by the study team: 2023-09-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.