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Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone Enanthate
Finasteride
Placebo injection
Placebo pill
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

testosterone enanthate, finasteride

placebo treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent Change in Hip Bone Mineral Density
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
Percent Changes in Muscle Cross-Sectional Area
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
Percent Change in Total Body Fat
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
Absolute Change in Walking Speed
Absolute change in 10 m walking speed

Secondary Outcome Measures

Percent Change in Neuromuscular Function
Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry
Percent Change in Visceral Fat
Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA)

Full Information

First Posted
September 22, 2014
Last Updated
September 27, 2023
Sponsor
VA Office of Research and Development
Collaborators
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02248701
Brief Title
Testosterone Plus Finasteride Treatment After Spinal Cord Injury
Official Title
Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment difficulties
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Florida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
testosterone enanthate, finasteride
Arm Type
Experimental
Arm Description
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Arm Title
placebo treatment
Arm Type
Placebo Comparator
Arm Description
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Intervention Type
Drug
Intervention Name(s)
Testosterone Enanthate
Other Intervention Name(s)
delatestryl
Intervention Description
Subjects receive testosterone (125 mg/week) by intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
proscar
Intervention Description
Subjects receive finasteride (5 mg/day) orally
Intervention Type
Drug
Intervention Name(s)
Placebo injection
Other Intervention Name(s)
sesame oil
Intervention Description
Subjects receive placebo (weekly) by intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Other Intervention Name(s)
inactive substance
Intervention Description
Subjects receive placebo pill (daily) orally
Primary Outcome Measure Information:
Title
Percent Change in Hip Bone Mineral Density
Description
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
Time Frame
Baseline, 6 months, 12 months
Title
Percent Changes in Muscle Cross-Sectional Area
Description
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
Time Frame
Baseline, 6 months, 12 months
Title
Percent Change in Total Body Fat
Description
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline, 6 months, 12 months
Title
Absolute Change in Walking Speed
Description
Absolute change in 10 m walking speed
Time Frame
Baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Percent Change in Neuromuscular Function
Description
Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry
Time Frame
Baseline, 6 months, 12 months
Title
Percent Change in Visceral Fat
Description
Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA)
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants must be male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua F Yarrow, PhD MS BS
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana M Otzel, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research & Development.
IPD Sharing Time Frame
Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research & Development.
IPD Sharing Access Criteria
Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research & Development.

Learn more about this trial

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

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