Testosterone Nasal Gel for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Noam Y Harel, MD PhD

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: VA Office of Research and Development

Must not be taking: Amphetamines, Neuroleptics, others

Disqualifiers: Seizures, Ventilator dependence, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a single dose of testosterone nasal gel affects nerve and autonomic nervous system (ANS) function in men with spinal cord injuries (SCI). The researchers aim to determine if this treatment can improve issues like movement and heart rate control, which are often disrupted after SCI. Participants will receive either the testosterone gel or a placebo (a harmless fake treatment). Men who have had a spinal cord injury for over a year and experience low testosterone levels affecting daily life might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have a stable prescription medication regimen for at least 30 days before joining. You cannot be on treatment for low testosterone or use medications that lower the seizure threshold.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Natesto, a testosterone nasal gel, has been safely used by individuals with low testosterone. Participants used it for three months, with safety checks extending up to six months. During this period, researchers tracked any side effects, noting their frequency and severity.

Although specific safety information for individuals with spinal cord injuries is not yet available, the FDA has approved Natesto for other uses. This approval suggests general safety, but using it for spinal cord injuries remains a new area of study.

In summary, while testing for spinal cord injury is just beginning, past use in other contexts suggests it might be well-tolerated. However, further research is necessary to fully understand its safety for individuals with spinal cord injuries. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spinal cord injury?

Researchers are excited about Natesto testosterone intranasal gel for spinal cord injury because it offers a unique delivery method compared to traditional testosterone therapies. Unlike injections or patches, Natesto is administered through a nasal gel, which could provide more stable and rapid absorption into the bloodstream. This method has the potential to minimize the fluctuations in testosterone levels that are common with other forms of therapy. Additionally, the convenience of a nasal application might improve patient compliance, making it a promising option for those with mobility challenges due to spinal cord injuries.

What evidence suggests that Natesto testosterone intranasal gel might be an effective treatment for spinal cord injury?

This trial will compare the effects of testosterone nasal gel (Natesto) with a placebo in men with spinal cord injuries. Research has shown that testosterone nasal gel can quickly improve nerve function in people without spinal injuries. Up to 60% of men with spinal cord injuries have low testosterone, which can worsen nerve and nervous system issues. Studies have found that testosterone therapy can enhance muscle strength and heart health in men with spinal cord injuries. In men with low testosterone, 77% reached normal levels using the gel. These findings suggest that the gel might also improve nerve and nervous system function in men with spinal cord injuries. ^{1 2 3 4 6}

Who Is on the Research Team?

Jacob A Goldsmith, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My medication has not changed in the last 30 days.

I am not on medication for low testosterone.

Time since injury (TSI) more than 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of intranasal testosterone replacement therapy (TRT) or placebo to assess neurophysiological and cardiovagal responses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including electromyographic responses and cardiovagal function

up to 1 day

What Are the Treatments Tested in This Trial?

Interventions

• Natesto testosterone intranasal gel

Trial Overview 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.

How Is the Trial Designed?

Group I: Intranasal TRT Active Control 1 Intervention

Participant-blinded (11 mg of Natesto)

Group II: Placebo Placebo Group 1 Intervention

Participant-blinded (Ayr Saline Gel)

Natesto testosterone intranasal gel is already approved in United States, Canada for the following indications:

Approved in United States as Natesto for:

• Hypogonadism

Approved in Canada as Natesto for:

• Hypogonadism

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of hypogonadal males treated with testosterone nasal gel (TNG) for 90 days, 77% of patients achieved normal testosterone levels, indicating the efficacy of TNG in managing testosterone deficiency.

The study highlighted that while many patients were up-titrated to a higher dose based on physician assessments, there was no significant improvement in symptom scores at the higher dose, suggesting that initial dosing based on symptoms may be sufficient for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MY-T study: Symptom-based titration decisions when using testosterone nasal gel, Natesto&#174;. Lee, J., Brock, G., Barkin, J., et al.[2022]

Natesto nasal gel, administered three times daily, effectively raises low testosterone levels to the normal range in patients with hypogonadism, offering a potential alternative to traditional testosterone treatments.

The FDA has cautioned against using testosterone therapy solely for age-related hypogonadism due to safety concerns and insufficient evidence of benefit in older men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone nasal gel (Natesto) for hypogonadism. [2015]

In a study of 117 hypogonadal men (24 TTh-naive and 93 TTh-experienced) over 120 days, the testosterone nasal gel (Natesto®) significantly improved symptoms and patient satisfaction compared to previous topical testosterone treatments.

Patients reported a 15% improvement in symptoms and a 30% increase in convenience with Natesto®, with 67.2% preferring it over topical options, suggesting that its ease of use may enhance treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The My-T study: Patient satisfaction and preference comparing topical and nasal testosterone therapies. Lee, J., Brock, G., Barkin, J., et al.[2022]

In a study of 60 men with symptomatic hypogonadism, 90.9% achieved normal testosterone levels after 6 months of treatment with 4.5% nasal testosterone gel (Natesto), indicating its efficacy in raising testosterone levels.

The treatment maintained normal sperm counts in 93.9% of participants at 6 months, suggesting that Natesto is a safe option for men with hypogonadism who want to preserve their fertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Natesto on Reproductive Hormones, Semen Parameters and Hypogonadal Symptoms: A Single Center, Open Label, Single Arm Trial. Ramasamy, R., Masterson, TA., Best, JC., et al.[2021]

The pharmacokinetics of testosterone nasal gel (TNG) show that allergic rhinitis (AR) does not affect the absorption of testosterone, indicating that TNG can be safely used in patients with AR.

In a large phase 3 study involving 306 hypogonadal patients, treatment outcomes with TNG were similar for both AR and non-AR patients, suggesting that AR history does not impact the effectiveness or safety of TNG over long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies. Rogol, AD., Tkachenko, N., Badorrek, P., et al.[2022]

Citations

1. withpower.com withpower.com/trial/testosterone-nasal-gel-for-spinal-cord-injury-140d3

Testosterone Nasal Gel for Spinal Cord Injury In a study of hypogonadal males treated with testosterone nasal gel (TNG) for 90 days, 77% of patients achieved normal testosterone levels, indicating the ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06130449/testosterone-and-neural-function

Testosterone and Neural Function | Clinical Research Trial ... Interestingly, up to 60% of men with SCI exhibit persistently low T concentrations, which may worsen nerve and ANS dysfunction. In uninjured ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9968415/

A Systematic Review of Testosterone Therapy in Men With ... Testosterone therapy with exercise may help improve muscle mass, bone health, strength, energy expenditure, and cardiac health in men with SCI without major ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/205488s005lbl.pdf

highlights of prescribing information - accessdata.fda.gov Natesto (testosterone) nasal gel is a slightly yellow gel containing 5.5 mg of testosterone in. 122.5 mg of Natesto gel for nasal administration. The active ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6694041/

Efficacy of Nasal Testosterone Gel (Natesto®) Stratified by ... Pharmacokinetic and efficacy data from a phase 3 testosterone nasal gel (TNG) study were stratified by baseline endogenous testosterone level in patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03281187

Efficacy and Safety of Testosterone Nasal Gel for Treating ... Safety evaluation data will include report of all adverse events, including type, frequency, intensity, seriousness, severity and action taken related to the ...