Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen ByOmar 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.

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

My testosterone levels were below 300 ng/dl on two morning tests.

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

My condition is stable and not currently worsening.

I am not currently experiencing a relapse.

Exclusion Criteria

My BMI is 35 or higher.

I have a skin condition like psoriasis that could affect how my skin absorbs medications.

I have tested positive for HIV, HTLV1, or had a positive VDRL test.

I am currently taking Finasteride.

I am a woman or a man who does not meet certain criteria.

I have a history of pituitary gland disease.

I show signs of having Lyme disease.

I have had or currently have a lump on my testicle.

I am a male who has been on hormone treatment for a condition in the past year.

I am on blood thinners or have serious health issues including heart, lung, kidney, liver diseases, diabetes, or cancer.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Treatment open label armExperimental Treatment1 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.