Testosterone Plus Finasteride Treatment After Spinal Cord Injury

NCT02248701 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: B1449-R1I01RX001449-01A1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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)

  Baseline, 6 months, 12 months

• 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

  Baseline, 6 months, 12 months

• Percent Change in Total Body Fat

  Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)

  Baseline, 6 months, 12 months

• Absolute Change in Walking Speed

  Absolute change in 10 m walking speed

  Baseline, 6 months, 12 months

Secondary Outcomes (2)

• Percent Change in Neuromuscular Function

  Baseline, 6 months, 12 months

• Percent Change in Visceral Fat

  Baseline, 6 months, 12 months

Study Arms (2)

testosterone enanthate, finasteride

EXPERIMENTAL

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

Drug: Testosterone Enanthate; Drug: Finasteride

placebo treatment

PLACEBO COMPARATOR

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

Drug: Placebo injection; Drug: Placebo pill

Interventions

Testosterone Enanthate DRUG

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

Also known as: delatestryl

testosterone enanthate, finasteride

Finasteride DRUG

Subjects receive finasteride (5 mg/day) orally

Also known as: proscar

testosterone enanthate, finasteride

Placebo injection DRUG

Subjects receive placebo (weekly) by intramuscular injection

Also known as: sesame oil

placebo treatment

Placebo pill DRUG

Subjects receive placebo pill (daily) orally

Also known as: inactive substance

placebo treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Florida: collaborator

Study Sites (2)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Otzel DM, Nichols L, Conover CF, Marangi SA, Kura JR, Iannaccone DK, Clark DJ, Gregory CM, Sonntag CF, Wokhlu A, Ghayee HK, McPhaul MJ, Levy CE, Plumlee CA, Sammel RB, White KT, Yarrow JF. Musculoskeletal and body composition response to high-dose testosterone with finasteride after chronic incomplete spinal cord injury-a randomized, double-blind, and placebo-controlled pilot study. Front Neurol. 2024 Dec 11;15:1479264. doi: 10.3389/fneur.2024.1479264. eCollection 2024.

  PMID: 39722695 DERIVED

MeSH Terms

Conditions

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; Bone Resorption; Motor Activity

Interventions

testosterone enanthate; Finasteride; Sesame Oil

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

This trial was terminated early due to enrollment and retention difficulties that persisted during the severe acute respiratory syndrome (SARS)-Cov19 pandemic. This resulted in a smaller number of subjects being enrolled and undergoing testing than was originally planned in our a priori analysis.

Results Point of Contact

• Title: Joshua Yarrow, MS, PhD
• Organization: North Florida/South Georgia Veterans Health System

Joshua.Yarrow@va.gov

(352) 548-6477

Study Officials

• Joshua F Yarrow, PhD MS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

• Dana M Otzel, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: April 27, 2017
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: September 29, 2023
• Results First Posted: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.
• Access Criteria: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.

Locations

US (2)