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NCT06130449 · ClinicalTrials.gov registry record · Early Phase 1
Testosterone and Neural Function
A Early Phase 1 study of Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06130449 is a Early Phase 1 study of Spinal Cord Injury that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 15 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06130449, a Early Phase 1 study of Spinal Cord Injury, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Natesto testosterone intranasal gel
- DRUG Ayr Saline Nasal Gel
Study Locations (1)
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2026-09-30 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06130449
The ClinicalTrials.gov registry entry for NCT06130449 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (83% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Natesto testosterone intranasal gel is the first listed.
NCT06130449 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06130449 about?
NCT06130449 is a clinical study titled "Testosterone and Neural Function". 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 impa...
What is the current status of trial NCT06130449?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2024-04-01. Estimated completion is 2026-09-30.
What conditions does trial NCT06130449 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT06130449?
The interventions under investigation include: Natesto testosterone intranasal gel (DRUG), Ayr Saline Nasal Gel (DRUG).
Who is sponsoring clinical trial NCT06130449?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06130449 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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