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Could a single dose of testosterone boost nerve function in spinal cord injury?

NCT ID NCT06130449

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study looks at how a single dose of intranasal testosterone affects nerve and autonomic function in 15 male veterans with spinal cord injury who have low testosterone. Researchers will measure muscle responses and heart rate changes before and after the dose. The goal is to understand if testosterone can improve nerve signaling and autonomic reflexes in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
testosterone intranasal gel
What this could lead to
If it works, this could point toward a way to improve nerve and autonomic function in men with spinal cord injury.
What could go wrong
This is a very early, small study with only 15 participants. It tests a single dose, so any effects may be temporary or not translate to long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male * Hypogonadal (Serum Total T \<300 ng/dL, Free T \<46 pg/mL, or bioavailable T \<110 ng/dL) with signs/symptoms of hypogonadism * Age 18-80 years * Traumatic or non-traumatic spinal cord injury (SCI) * Time since injury (TSI) more than 12 months * American Spinal Injury Association (ASIA) Injury classification Scale (AIS) A, B, C, or D * Stable prescription medication regimen for at least 30 days * Not currently receiving pharmacological treatment for hypogonadism * Must be able to commit to study requirements of 3 visits within a 30-day period * Provide informed consent Exclusion Criteria: * Extensive history of seizures * Ventilator dependence or patent tracheostomy site * History of neurologic disorder other than SCI * History of moderate or severe head trauma * Currently receiving treatment for hypogonadism * History of allergy, hypersensitivity, or other significant adverse reaction to testosterone replacement therapy * Significant cardiovascular disease or cardiac conduction disease * Active psychological disorder * Moderate or severe brain injury, stroke, tumor, multiple sclerosis, or abscess * Recent history (within 3 months) of substance abuse * Pressures sores stage 3 or greater * Active infection * Frequent severe migraines * Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures) * History of implanted devices with electromagnetic properties: brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation * Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • James J. Peters VA Medical Center, Bronx, NY

    RECRUITING

    The Bronx, New York, 10468-3904, United States

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