Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Overseen By Michael Soliman, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Tulane University

Must not be taking: Anticoagulants, Finasteride

Disqualifiers: Cardiac, Pulmonary, Renal, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a testosterone injection called Xyosted in older men with Multiple Sclerosis who have low testosterone. The goal is to see if it can improve their energy, mood, thinking skills, and overall quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you have been on sex hormone treatments in the past year, taken DHEA in the past 3 months, or are on certain medications like anticoagulants or Finasteride.

What data supports the effectiveness of the drug XYOSTED for treating erectile dysfunction in patients with multiple sclerosis?

Research shows that testosterone therapy can improve erectile function in men with low testosterone levels, even when they do not respond to other treatments. This suggests that testosterone treatments like XYOSTED might help with erectile dysfunction by increasing testosterone levels. ^{1 2 3 4 5}

Is testosterone treatment generally safe for humans?

Testosterone treatment is generally considered safe for humans, with benefits for sexual function, muscle mass, mood, and cognitive function. There is no consistent evidence linking it to increased prostate cancer risk, and recent studies suggest it may reduce cardiovascular risk, especially with long-acting injections. However, potential side effects like fluid retention and changes in prostate health should be monitored. ^{4 6 7 8 9}

How does the drug XYOSTED differ from other treatments for erectile dysfunction and multiple sclerosis?

XYOSTED is unique because it is a testosterone therapy administered via injection, which may help improve erectile function in men with low testosterone levels. Unlike other treatments that focus solely on erectile dysfunction, XYOSTED addresses the underlying issue of testosterone deficiency, potentially offering benefits for both erectile dysfunction and symptoms related to multiple sclerosis. ^{1 4 10 11 12}

Research Team

Omar A Raheem, MD

Principal Investigator

Assistant Professor, Urology

Eligibility Criteria

This trial is for male Multiple Sclerosis patients over 18 with low testosterone levels, experiencing erectile dysfunction and libido issues. Participants must be sexually active, not in a relapse phase, able to complete various health questionnaires, and commit to the study schedule.

Inclusion Criteria

I am sexually active.

I am a man over 18 with a confirmed diagnosis of multiple sclerosis.

I am willing to complete tests, questionnaires, and attend all scheduled visits.

Exclusion Criteria

I meet all the safety requirements set by the treatment's manufacturer.

You are currently struggling with alcohol addiction.

You have a serious mental illness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline visit includes providing a blood sample, completing questionnaires, receiving training on the Xyosted auto-injector, and undergoing a rectal exam for participants 55 years and older

1 day

1 visit (in-person)

Treatment

Participants receive Xyosted 75 mg subcutaneously once per week for 3 months, with study visits every 6 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• XYOSTED

Trial Overview The trial tests if XYOSTED (testosterone) injections can improve sexual function, mood, cognitive abilities, life quality, bladder control and pain in men with MS and low testosterone. It involves blood tests and assessments through questionnaires.

Participant Groups

Group I: Treatment open label arm Experimental Treatment 1 Intervention

Open-label feasibility study to determine the effects of testosterone (Xyosted 75mg subcutaneous once per week for 3 months) on erectile function in male Multiple Sclerosis patients with low testosterone.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

Antares Pharma Inc.

Industry Sponsor

Trials

11

Recruited

1,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of testosterone on erectile function: implications for the therapy of erectile dysfunction. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of testosterone administration on sexual behavior and mood in men with erectile dysfunction. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Testosterone Therapy for Late-Onset Hypogonadism Improves Erectile Function: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Testosterone improves erectile function in hypogonadal patients with venous leakage. [2013]

6. England pubmed.ncbi.nlm.nih.gov

An update on the role of testosterone replacement therapy in the management of hypogonadism. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The androgen-deficient aging male: current treatment options. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Potential adverse effects of long-term testosterone therapy. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy and Mortality in Older Men. [2018]

10. England pubmed.ncbi.nlm.nih.gov

The relationship between hypogonadism and erectile dysfunction. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Does sildenafil combined with testosterone gel improve erectile dysfunction in hypogonadal men in whom testosterone supplement therapy alone failed? [2015]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The role of testosterone drugs in combined therapy of erectile dysfunction in patients with metabolic syndrome]. [2017]