Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Overseen by Omar A Raheem, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Tulane University

No Placebo Group

Prior Safety Data

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.

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.

Treatment Details

Interventions

• XYOSTED (Androgen Replacement Therapy)

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+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

J. Christian Winters

Louisiana State University Health Sciences Center in New Orleans

Chief Executive Officer

MD

Jayne Weiss

Louisiana State University Health Sciences Center in New Orleans

Chief Medical Officer

MD

Antares Pharma Inc.

Industry Sponsor

Trials

11

Recruited

1,200+