Testosterone for Spinal Cord Injury

Overseen By Andrew Park, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Craig Hospital

Must not be taking: Statins, Beta-blockers

Disqualifiers: Cardiovascular disease, Smoking, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how testosterone affects blood vessel health in men with spinal cord injuries (SCI). Individuals with SCI often face a higher risk of heart attacks and strokes, and the study aims to understand the underlying causes. Researchers focus on how testosterone might improve the function of the cells lining the blood vessels. Suitable candidates for this trial include males with a spinal cord injury within the last six months and low testosterone levels.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance heart health for individuals with SCI.

Will I have to stop taking my current medications?

If you are taking medications that affect the heart or blood vessels, like statins or beta-blockers, you may need to stop them to join this trial. The trial excludes participants with a history of using such medications.

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

Research shows that testosterone therapy can be safe for men with spinal cord injuries (SCI). Studies have found it improves muscle strength, bone health, and heart health without major issues. One small study focused on men with SCI and found that testosterone therapy was well-tolerated. Participants experienced improvements in muscle mass and energy use, which are positive results.

Another study noted that men with low testosterone levels after SCI often face more health issues, suggesting that testosterone therapy might help reduce some of these risks. Overall, research indicates that testosterone therapy is generally safe and could offer health benefits for men with SCI. However, as with any treatment, discussing options with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using testosterone for spinal cord injury because it offers a novel approach by potentially enhancing nerve regeneration and recovery. Current treatments focus on managing symptoms and preventing further damage, but testosterone may help repair the spinal cord itself. This hormone could work by promoting the growth of nerve cells and improving muscle strength, which are crucial for recovery. If successful, testosterone could significantly improve the quality of life for individuals with spinal cord injuries.

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

Research has shown that testosterone therapy might improve heart health in men with spinal cord injuries (SCI). Studies have found that testosterone can enhance muscle and bone health, which are crucial for maintaining healthy heart and blood vessels. In this trial, some participants with low testosterone levels will receive testosterone therapy to assess its effects. Men with SCI often experience low testosterone levels, which can harm the inner lining of their blood vessels. This lining, called the endothelium, plays a vital role in preventing heart attacks and strokes. Testosterone therapy has been shown to improve blood vessel function. Overall, replacing testosterone appears promising in reducing heart risks for men with SCI. ^{1 2 5 6 7}

Who Is on the Research Team?

Andrew Park, MD

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 89 years old.

I am male.

I have complete paralysis from the mid-chest down.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of endothelial function and microvesicle concentration are taken

1 week

1 visit (in-person)

Treatment

Participants undergo pharmacological manipulation to assess endothelial function

1 week

Multiple visits (in-person) for drug infusion and measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone

How Is the Trial Designed?

Group I: Adult Male with Subacute Traumatic Spinal Cord Injury with Normal Testosterone Experimental Treatment 3 Interventions

24 male participants of all races and ethnic backgrounds aged 18-89 years with a history of spinal cord injury and diagnosed with normal testosterone

Group II: Adult Male with Subacute Traumatic Spinal Cord Injury with Low Testosterone Experimental Treatment 3 Interventions

24 male participants of all races and ethnic backgrounds aged 18-89 years with a history of spinal cord injury and diagnosed with low testosterone

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00266864

Testosterone Replacement Therapy in Chronic Spinal ... ... efficacy of testosterone replacement therapy in hypogonadal men with spinal cord injury. Horm Metab Res. 2011 Jul;43(8):574-9. doi: 10.1055/s-0031-1280797 ...

3. journals.lww.com journals.lww.com/nrronline/fulltext/2021/16080/low_dose_testosterone_replacement_therapy_and.17.aspx

Low-dose testosterone replacement therapy and electrically... Low-dose testosterone replacement therapy and electrically evoked resistance training enhance muscle quality after spinal cord injury.

4. nature.com nature.com/articles/3101370

Effects of testosterone replacement therapy on skeletal ... Conclusions: TRT was effective in attenuating alterations in myofibrillar proteins during 11 weeks of SCI in affected skelatal muscles.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148211004680

Prevalence of Testosterone Deficiency After Spinal Cord ... A low serum testosterone level (<325 ng/dL) was detected in 43.3% of participants. The testosterone level was significantly associated with severity of injury.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21717386/

A small-scale clinical trial to determine the safety and ... In conclusion, testosterone replacement therapy significantly improved lean tissue mass and energy expenditure in hypogonadal men with spinal cord injury, ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1479264/full

Musculoskeletal and body composition response to high- ... A small-scale clinical trial to determine the safety and efficacy of testosterone replacement therapy in hypogonadal men with spinal cord injury. Horm Metab ...