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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how testosterone treatment affects various health aspects for men with both low testosterone and Multiple Sclerosis (MS). The focus includes improving erectile function, fatigue, mood, thinking skills, and overall quality of life. Participants receive a testosterone injection called XYOSTED once a week for three months. Men with MS who have experienced issues with erectile function and have confirmed low testosterone might be suitable candidates. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for this treatment?

Research has shown that testosterone treatments like XYOSTED are generally safe and well-tolerated. In past studies, patients did not experience significant negative effects from testosterone treatment. It might even help protect nerves. The FDA has already approved this treatment for other uses, which supports its safety. Always consult a healthcare provider to determine if it's suitable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for erectile dysfunction, which typically include oral medications like Viagra or Cialis, XYOSTED offers a novel approach by addressing low testosterone levels in male patients with Multiple Sclerosis (MS). This treatment is unique because it involves a weekly subcutaneous injection of testosterone, which could provide a more consistent and manageable hormone level than daily pills. Researchers are excited about XYOSTED because it targets the underlying hormonal imbalance that may contribute to both erectile dysfunction and MS symptoms, potentially offering dual benefits for patients with these complex conditions.

What evidence suggests that testosterone treatment might be effective for erectile dysfunction in male Multiple Sclerosis patients?

Research shows that testosterone therapy, such as XYOSTED, can improve erectile function in men with low testosterone levels. Studies have found that men with erectile dysfunction often have lower testosterone. In this trial, participants will receive XYOSTED, a specialized testosterone treatment administered through injections, to evaluate its effects on erectile function in male Multiple Sclerosis patients with low testosterone. This treatment might also alleviate tiredness, depression, and cognitive issues in men with low testosterone and multiple sclerosis. Experts agree that testosterone treatment effectively improves erectile function in men with low testosterone. ^{1 2 4 6 7}

Who Is on the Research Team?

Omar A Raheem, MD

Principal Investigator

Assistant Professor, Urology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-4-multiple-sclerosis-7-2021-2cd51

Testosterone Treatment for Erectile Dysfunction and ... XYOSTED is unique because it is a testosterone therapy administered via injection, which may help improve erectile function in men with low testosterone levels.

2. academic.oup.com academic.oup.com/smr/article/13/4/513/8221489

Evolving medical management of erectile dysfunction ... To review the current data on pharmacotherapy for erectile dysfunction based on efficacy, psychosocial outcomes, and safety outcomes. Methods. A review of ...

3. smartpatients.com smartpatients.com/trials/NCT04601233

Testosterone Treatment for Erectile Dysfunction and ... The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function ...

4. naturemedclinic.com naturemedclinic.com/latest-advancements-in-the-integrative-treatment-of-erectile-dysfunction-and-sexual-dysfunction-in-men/

Advancements in Treatment of Erectile & Sexual Dysfunction Cabergoline treatment resulted in improvement in erectile function, sexual desire, orgasmic function, and the patient's and the partner's sexual ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5656369/

Increased risk of erectile dysfunction in men with multiple ... In the present study, erectile dysfunction (ED) patients presented a mean lower testosterone levels compared to non-erectile dysfunction (ED) patients (Table 4 ...

6. trial.medpath.com trial.medpath.com/clinical-trial/bf6ec48b7e56d53b/nct04601233-testosterone-treatment-erectile-dysfunction-ms

Testosterone Treatment for Erectile Dysfunction and Multiple ... Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis. Phase 4. Not yet recruiting. Conditions. Erectile Dysfunction. Multiple Sclerosis.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17502467/

Testosterone treatment in multiple sclerosis: a pilot study Conclusion: These exploratory findings suggest that testosterone treatment is safe and well tolerated and has potential neuroprotective effects in men with ...