Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

This study is looking at how a self-injected testosterone treatment called XYOSTED 75 mg might help men with Multiple Sclerosis (MS) who also have low testosterone and erectile dysfunction. Researchers want to see if XYOSTED improves erectile function, and they will measure this using three different questionnaires (ADAM, SHIM, and MSHQ-SF) after 12 weeks of treatment. To join, you must be a man aged 18 or older with a definite MS diagnosis, low testosterone (below 300 ng/dl on two separate blood tests), and currently experiencing issues with erectile function and libido. You also cannot be in an MS relapse. The study aims to enroll 20 participants, but its current status is unclear.

Study design: This is an interventional study with 20 planned participants. It is not specified if it is randomized or blinded.
What's involved: You would receive weekly XYOSTED injections for 3 months and attend 3 study visits over that time. These visits include blood samples, questionnaires, and a rectal exam if you are 55 or older.
Compensation: Not stated in the trial record.
Follow-up: Your erectile function will be measured at 12 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Not Yet Recruiting

PHASE4Ages 18+InterventionalTreatment

Tulane University

~20 participants

Updated 2025-08-29 on ClinicalTrials.gov

What's tested:XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Androgen Deficiency in the Aging Male (ADAM score).

Measured over Change from baseline to 12 weeks

+2 more outcomes measured

Conditions

Multiple Sclerosis

Erectile Dysfunction

Testosterone Deficiency

Where it's being run

1 sites across 1 states

Louisiana1

Study leadership

Omar A Raheem, MD · PRINCIPAL_INVESTIGATOR · Assistant Professor, Urology

Who to contact

Michael Soliman, MD

[email protected]

504-756-4603

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males, age 18 years and older, with a definite diagnosis of multiple sclerosis.

Low testosterone (\<300 ng/dl) on two successive blood draws before 9:00 am

Not in an intercurrent relapse.

Sexually active.

Have subjective complaints about erectile function and libido.

Must be willing and able to get labs drawn, complete questionnaires (BDI, MFIS, MSNQ, SDMT, MSQOL, ADAM, AUASS, SHIM, MSHQ, ICIQ, UDI, IIQ, MPQ) and commit to site visits schedule.

Exclusion

Males unable to fulfill the above criteria and all female patients.

Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.

Males who have taken dehydroepiandrosterone (DHEA) during the 3 months prior to study.

Patients who are taking anticoagulants or have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), urologic disease especially prostatic hypertrophy/nodules and testicular mass, or insulin-dependent diabetes.

Patients with an abnormal prostate as evidenced by known history of prostatic disease, symptoms suggestive of prostatic disease or elevated levels of prostatic specific antigen (PSA 4 ng/ml or higher) measured within the last 12 months.

Patients with history or complaint of testicular mass.

Patients with hematocrit greater than 50%

Patients with major psychiatric illness

Patients with active alcoholism.

Patients with a history of drug abuse within the past five years.

Patients with BMI ≥ 35

Patients with generalized skin disease that may affect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.

Patients with history of pituitary disease.

Patients with a cholesterol level greater than 300 mg/dl.

Patients who are receiving or have received experimental therapies in the six months preceding enrollment.

Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).

Patients who have clinical evidence of Lyme disease.

Males who are trying to get their partner pregnant.

Patients on Finasteride

Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.

What this trial measures

Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Androgen Deficiency in the Aging Male (ADAM score).Change from baseline to 12 weeks
Androgen Deficiency in the Aging Male (ADAM score) includes ten "Yes or No" questions, with an answer "Yes" to number 1 or 7 or if you answer "Yes" to more than 3 questions, you may have low Testosterone.
Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Sexual Health in Men (SHIM score).Change from baseline to 12 weeks
Sexual Health in Men (SHIM score) with a range of 1 to 25 with a higher number representing less erectile dysfunction.
Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Male Sexual Health Questionnaire short form (MSHQ-SF).Change from baseline to 12 weeks
Male Sexual Health Questionnaire short form (MSHQ-SF) with a range of 1 to 15 with a higher number representing better ejaculatory function, in addition to one bother/satisfaction question, scored 1 to 5 where the higher represents more bothersome.

Trialytics