Testosterone Plus Finasteride Treatment After Spinal Cord Injury

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


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.


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.

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


Yes No Not Sure

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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note