Testosterone Plus Finasteride Treatment After Spinal Cord Injury

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

Interventions

DRUG

Testosterone Enanthate

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

DRUG

Finasteride

Subjects receive finasteride (5 mg/day) orally

DRUG

Placebo injection

Subjects receive placebo (weekly) by intramuscular injection

DRUG

Placebo pill

Subjects receive placebo pill (daily) orally

Sponsors & Collaborators

• University of Florida

  collaborator OTHER

• VA Office of Research and Development

  lead FED

Principal Investigators

• Joshua F Yarrow, PhD MS BS · North Florida/South Georgia Veterans Health System, Gainesville, FL

• Dana M Otzel, PhD · North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-27

Primary Completion

2021-08-13

Completion

2021-08-13

FDA Drug

Yes

Countries

• United States

Study Locations