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Testosterone and Neural Function in Men With Spinal Cord Injury

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 31, 2026
See other at-risk trials from VA Office of Research and Development

Record History

  1. Primary and study completion pushed from Sep 30, 2026 to Dec 31, 2026 Eligibility criteria expanded, about 34 words · Secondary endpoints: details revised at 1 of 2 entries · Study description revised · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Site contact updated
    • Study title expanded, about 6 words
  2. Primary completion date: Dec 31, 2025 to Sep 30, 2026 Completion date: Mar 31, 2026 to Sep 30, 2026 · Site contact updatedv4 Show 2 more changesShow less
    • Completion date: Mar 31, 2026 to Sep 30, 2026
    • Site contact updated
  3. Primary endpoint revised Eligibility criteria expanded, about 23 words · Study description expanded, about 19 words · Site contact updatedv3 Show 3 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 19 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06130449
Lead Sponsor VA Office of Research and Development
Conditions Spinal Cord Injury
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov