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Hormone Therapy

Testosterone Nasal Gel for Spinal Cord Injury

Phase < 1
Recruiting
Led By Jacob A Goldsmith, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not currently receiving pharmacological treatment for hypogonadism
Traumatic or non-traumatic SCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one day

Summary

This trial will evaluate if a single dose of testosterone improves nerve and autonomic nervous system (regulates heart rate, etc.) function in men with spinal cord injury.

Who is the study for?
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.
What is being tested?
The study examines the effects of Natesto, an intranasal testosterone gel, on nerve and autonomic nervous system function in men with SCI. It compares these effects against Ayr Saline Nasal Gel, which does not contain hormones.
What are the potential side effects?
Potential side effects may include nasal irritation from the gels. Testosterone can also cause mood swings, increased red blood cell count, acne, sleep apnea, or changes in cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on medication for low testosterone.
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I have a spinal cord injury.
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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Electromyographic responses
Secondary study objectives
Cardiovagal Function (heart rate variability)
Serum Testosterone

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intranasal TRTActive Control1 Intervention
Participant-blinded (11 mg of Natesto)
Group II: PlaceboPlacebo Group1 Intervention
Participant-blinded (Ayr Saline Gel)

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,633 Total Patients Enrolled
Jacob A Goldsmith, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
~10 spots leftby Dec 2025
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