Testosterone Nasal Gel for Spinal Cord Injury
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must have a stable prescription medication regimen for at least 30 days before joining. You cannot be on treatment for low testosterone or use medications that lower the seizure threshold.
Is testosterone nasal gel safe for humans?
Testosterone nasal gel, known as Natesto, has been used to treat low testosterone levels in men, but the FDA has warned against its use for age-related low testosterone due to safety concerns. It is generally applied in the nose and has been studied in people with allergies, but specific safety data for spinal cord injury is not available.12345
How is the drug Natesto different from other treatments for spinal cord injury?
Research Team
Jacob A Goldsmith, PhD
Principal Investigator
James J. Peters Veterans Affairs Medical Center
Eligibility Criteria
This trial is for men aged 18-80 with spinal cord injury (SCI), either traumatic or non-traumatic, who have stable medication use and are not on testosterone treatment. They must be at least a year post-injury and able to commit to three study visits in a month.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of intranasal testosterone replacement therapy (TRT) or placebo to assess neurophysiological and cardiovagal responses
Follow-up
Participants are monitored for safety and effectiveness after treatment, including electromyographic responses and cardiovagal function
Treatment Details
Interventions
- Natesto testosterone intranasal gel (Hormone Therapy)
Natesto testosterone intranasal gel is already approved in Canada for the following indications:
- Hypogonadism
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor