Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02248701
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Terminated
Phase	Phase 2
Start date	April 27, 2017
Completion date	August 13, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06321172` - Muscle and Bone Changes After 6 Months of FES Cycling	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05484557` - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury	N/A
Suspended	`NCT05542238` - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Not yet recruiting	`NCT05506657` - Early Intervention to Promote Return to Work for People With Spinal Cord Injury	N/A
Recruiting	`NCT04105114` - Transformation of Paralysis to Stepping	Early Phase 1
Recruiting	`NCT03680872` - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System	N/A
Completed	`NCT04221373` - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation	N/A
Completed	`NCT00116337` - Spinal Cord Stimulation to Restore Cough	N/A
Completed	`NCT03898700` - Coaching for Caregivers of Children With Spinal Cord Injury	N/A
Recruiting	`NCT04883463` - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury	N/A
Active, not recruiting	`NCT04881565` - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)	N/A
Completed	`NCT04864262` - Photovoice for Spinal Cord Injury to Prevent Falls	N/A
Recruiting	`NCT04007380` - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI	N/A
Active, not recruiting	`NCT04544761` - Resilience in Persons Following Spinal Cord Injury
Terminated	`NCT03170557` - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation	N/A
Completed	`NCT03220451` - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients	N/A
Recruiting	`NCT04811235` - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial	N/A
Recruiting	`NCT04736849` - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.