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Testosterone Plus Finasteride Treatment After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02248701
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: testosterone enanthate, finasteride Drug: placebo Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 1, 2019


Arm Intervention/treatment
Experimental: testosterone enanthate, finasteride
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Drug: testosterone enanthate, finasteride
Subjects receive testosterone (125 mg/week) by intramuscular injection and finasteride (5 mg/day) orally
Other Name: delatestryl, proscar

Placebo Comparator: placebo treatment
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Drug: placebo
Subjects receive weekly placebo injection and placebo pill daily




Primary Outcome Measures :
  1. Change in Hip Bone Mineral Density [ Time Frame: Baseline, 6 months, 12 months ]
    Change in hip bone mineral density assessed via dual-energy X-ray absorptiometry (DXA)

  2. Changes in Muscle Cross-Sectional Area [ Time Frame: Baseline, 6 months, 12 months ]
    Change in thigh muscle cross-sectional area assessed via MRI

  3. Change in Total Body Fat [ Time Frame: Baseline, 6 months, 12 months ]
    Change in total body fat assessed via DXA

  4. Change in Walking Speed [ Time Frame: Baseline, 6 months, 12 months ]
    Change in 10 m walking speed


Secondary Outcome Measures :
  1. Change in Neuromuscular Function [ Time Frame: Baseline, 6 months, 12 months ]
    Change in thigh muscle force production assessed via dynamometry

  2. Change in Visceral Fat [ Time Frame: Baseline, 6 months, 12 months ]
    Change in visceral fat mass assessed via DXA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be male
Accepts Healthy Volunteers:   No
Criteria

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 6 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 6 months
  • Baseline EKG findings (e.g. left bundle branch block) or marked EKG abnormalities that would preclude serial screening for occult ischemic events
  • History of or current prostate, breast, or other organ cancer
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248701


Contacts
Contact: Joshua F Yarrow, PhD MS BS (352) 376-1611 ext 6477 joshua.yarrow@va.gov
Contact: Dana M Otzel, PhD (352) 376-1611 ext 6917 Dana.Otzel@va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Joshua F Yarrow, PhD MS BS    352-376-1611 ext 6477    joshua.yarrow@va.gov   
Contact: Dana M Otzel, PhD    (352) 376-1611 ext 6917    Dana.Otzel@va.gov   
Principal Investigator: Joshua F Yarrow, PhD MS BS         
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Joshua F Yarrow, PhD    352-376-1611 ext 6477    Joshua.Yarrow@va.gov   
Contact: Dana M Otzel, PhD    3523761611 ext 6917    Dana.Otzel@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
University of Florida
Investigators
Principal Investigator: Joshua F Yarrow, PhD MS BS North Florida/South Georgia Veterans Health System, Gainesville, FL

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02248701     History of Changes
Other Study ID Numbers: B1449-R
1I01RX001449-01A1 ( U.S. NIH Grant/Contract )
1IK1RX002327-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
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

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases
Trauma, Nervous System
Hypogonadism
Spinal Cord Diseases
Genital Diseases, Male
Gonadal Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Finasteride
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bone Density Conservation Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Urological Agents