Testosterone and Neural Function

Part of paid clinical trials in The Bronx, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT06130449
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Natesto testosterone intranasal gel — DRUG
    A single dose of Natesto (11 mg total, 5.5 mg per nostril) will be administered to each participant.
  • Ayr Saline Nasal Gel — DRUG
    A single dose of Ayr (one spray per nostril) will be administered to each participant.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participant-blinded (Ayr Saline Gel)
  • Active Comparator: Intranasal TRT
    Participant-blinded (11 mg of Natesto)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical Center, Bronx, NYThe BronxNew York10468-3904
Dylan C Arnero, MA BA
[email protected]
718-584-9000
Caitlyn (Sig) N Sigafose, BS
[email protected]
(718) 584-9000
Jacob A Goldsmith, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in The Bronx, NY

By research site
James J. Peters VA Medical Center, Bronx, NY· The Bronx, NY

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