Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2021-08-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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testosterone enanthate, finasteride

Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)

Group Type EXPERIMENTAL

Testosterone Enanthate

Intervention Type DRUG

Subjects receive testosterone (125 mg/week) by intramuscular injection

Finasteride

Intervention Type DRUG

Subjects receive finasteride (5 mg/day) orally

placebo treatment

Placebo via i.m. injection (once weekly) and placebo pill orally (daily)

Group Type PLACEBO_COMPARATOR

Placebo injection

Intervention Type DRUG

Subjects receive placebo (weekly) by intramuscular injection

Placebo pill

Intervention Type DRUG

Subjects receive placebo pill (daily) orally

Interventions

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Testosterone Enanthate

Subjects receive testosterone (125 mg/week) by intramuscular injection

Intervention Type DRUG

Finasteride

Subjects receive finasteride (5 mg/day) orally

Intervention Type DRUG

Placebo injection

Subjects receive placebo (weekly) by intramuscular injection

Intervention Type DRUG

Placebo pill

Subjects receive placebo pill (daily) orally

Intervention Type DRUG

Other Intervention Names

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delatestryl proscar sesame oil inactive substance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No