Recruiting
Early Phase 1

Testosterone

Sponsor:

VA Office of Research and Development

Code:

NCT06130449

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Natesto testosterone intranasal gel

Ayr Saline Nasal Gel

Study Details

Brief 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

Spinal Cord Injury

Study ID

NCT06130449

Start date

Apr 1, 2024

Status verified date

Jan, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participant-blinded (Ayr Saline Gel)

active comparator: Intranasal TRT

Participant-blinded (11 mg of Natesto)

Interventions

Natesto testosterone intranasal gel

A single dose of Natesto (11 mg total, 5.5 mg per nostril) will be administered to each participant.

Ayr Saline Nasal Gel

A single dose of Ayr (one spray per nostril) will be administered to each participant.

Primary outcome measure

  • Electromyographic (EMG) responses [ Time Frame: up to one day ]

Central Contacts and Locations

Central contacts

Jacob A Goldsmith, PhD

(718) 584-9000Jacob.Goldsmith@va.gov

Noam Y Harel, MD PhD

(718) 584-9000Noam.Harel@va.gov

Locations

James J. Peters VA Medical Center, Bronx, NY

Recruiting

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

Contacts

Dylan C Arnero, MA BA

718-584-9000Dylan.Arnero@va.gov

Caitlyn (Sig) N Sigafose, BS

(718) 584-9000Caitlyn.Sigafose@va.gov

Principal Investigator:

Jacob A Goldsmith, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • spinal cord injury
  • testosterone
  • cardiovascular
  • neurophysiology
  • central nervous system
  • autonomic
  • motor function
  • electrical stimulation
  • cardiovagal function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-09.