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NCT06130449

Testosterone and Neural Function

The Role of Androgens in Neurophysiological and Autonomic Function in Male Veterans With Spinal Cord Injury
VA Office of Research and Development·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Spinal Cord Injury
Drug/Device/Intervention
Natesto testosterone intranasal gel
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
VA Office of Research and Development
Location
Bronx, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
Mar 31, 2026
Enrollment
15 participants
Primary outcome

Electromyographic responses

Summary

Spinal cord injury (SCI) disrupts the nerves controlling movement, along with those that
 regulate functions like heart rate and blood pressure (known as the autonomic nervous system,
 or ANS). Testosterone (T) plays a significant role in brain health and ANS reflex function in
 non-neurologically impaired men. However, little is known about the relationships between T,
 nerve function, and ANS dysfunction after SCI. Interestingly, up to 60% of men with SCI
 exhibit persistently low T concentrations, which may worsen nerve and ANS dysfunction. In
 uninjured eugonadal people (normal physiologic range of serum T concentrations), a single
 pharmacologic dose of intranasal T has been shown to quickly improve nerve function, but no
 study has evaluated if T administration alters nerve and ANS function in men with SCI.
 Herein, the investigators will conduct the first study to test how a single dose of
 intranasal T impacts motor and ANS function in this population.

ICD-10 classifications
Sequelae of injury of spinal cordOther injury of lumbar spinal cordInjury of spinal cord, level unspecifiedOther and unspecified injuries of thoracic spinal cordOther and unspecified injuries of cervical spinal cord
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06130449
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06130449 through Pure Global AI's free database. This Phase 1 trial is sponsored by VA Office of Research and Development and is currently Not yet recruiting. The study focuses on Spinal Cord Injury. Target enrollment is 15 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.