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Hormone Therapy

Testosterone Nasal Gel for Spinal Cord Injury

Q: Are elderly individuals being accepted for participation in this investigation?

In order to join this research project, potential participants must be above the age of majority and below 80 years old.

Q: Who would be the ideal candidate for this clinical investigation?

This clinical trial is currently seeking 15 participants who have <a href="https://www.withpower.com/clinical-trials/spinal-cord-injury">spinal cord injury</a> and are between 18-80 years old.

Q: Is enrollment for the trial still available?

Per the listing on clinicaltrials.gov, this trial is no longer accruing participants as it was last updated November 8th 2023 since its launch April 1st 2024. However, those seeking a medical study to join can explore 388 other opportunities that are actively enrolling right now.

Phase < 1

Recruiting

Led By Jacob A Goldsmith, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently receiving pharmacological treatment for hypogonadism

Traumatic or non-traumatic SCI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one day

Awards & highlights

Study Summary

This trial will evaluate if a single dose of testosterone improves nerve and autonomic nervous system (regulates heart rate, etc.) function in men with spinal cord injury.

Who is the study for?

This trial is for men aged 18-80 with spinal cord injury (SCI), either traumatic or non-traumatic, who have stable medication use and are not on testosterone treatment. They must be at least a year post-injury and able to commit to three study visits in a month.Check my eligibility

What is being tested?

The study examines the effects of Natesto, an intranasal testosterone gel, on nerve and autonomic nervous system function in men with SCI. It compares these effects against Ayr Saline Nasal Gel, which does not contain hormones.See study design

What are the potential side effects?

Potential side effects may include nasal irritation from the gels. Testosterone can also cause mood swings, increased red blood cell count, acne, sleep apnea, or changes in cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on medication for low testosterone.

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I have a spinal cord injury.

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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one day

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electromyographic responses

Secondary outcome measures

Cardiovagal Function (heart rate variability)

Serum Testosterone

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intranasal TRTActive Control1 Intervention

Participant-blinded (11 mg of Natesto)

Group II: PlaceboPlacebo Group1 Intervention

Participant-blinded (Ayr Saline Gel)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,269 Total Patients Enrolled

Jacob A Goldsmith, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being accepted for participation in this investigation?

"In order to join this research project, potential participants must be above the age of majority and below 80 years old."

Answered by AI

Who would be the ideal candidate for this clinical investigation?

"This clinical trial is currently seeking 15 participants who have spinal cord injury and are between 18-80 years old."

Answered by AI

Is enrollment for the trial still available?

"Per the listing on clinicaltrials.gov, this trial is no longer accruing participants as it was last updated November 8th 2023 since its launch April 1st 2024. However, those seeking a medical study to join can explore 388 other opportunities that are actively enrolling right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testosterone and Neural Function

2024. "Testosterone and Neural Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06130449.

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