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New treatment option for Spinal Cord Injury
Official title Testosterone and Neural Function
ClinicalTrials.gov ID: NCT06130449
What this study is testing
What is Natesto testosterone intranasal gel?
Natesto testosterone intranasal gel is an investigational medicine, being studied as a potential treatment for spinal cord injury.
Also referred to as testosterone intranasal gel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion.
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.