Phase 4 Multiple Sclerosis Trial, Not Yet Recruiting NCT04601233 Sponsor: Tulane University Condition: Multiple Sclerosis
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Phase 4 Multiple Sclerosis Trial, Not Yet Recruiting

NCT04601233
Not Yet Recruiting Phase 4

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Men aged 18 or older who have a confirmed diagnosis of multiple sclerosis.
  • Men with low testosterone levels (below 300 ng/dl), confirmed by two blood tests taken before 9:00 am.
  • Men who are not currently experiencing an MS relapse at the time of joining.
  • Men who are sexually active.
  • Men who have personal concerns about their erectile function and sex drive.
  • Men who are willing and able to attend scheduled site visits, have blood drawn, and complete a series of questionnaires about mood, fatigue, cognition, quality of life, and sexual and urinary function.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • Men who do not meet the inclusion criteria listed above, and all women.
  • Men who have used sex hormone treatments — including androgens, estrogens, or anti-estrogens — for low testosterone or any other medical reason in the 12 months before the study.
  • Men who have taken the supplement DHEA (dehydroepiandrosterone) in the 3 months before the study.
  • People who take blood-thinning medications, or who have a history of blood clots, or serious conditions affecting the heart, lungs, kidneys, digestive system, liver, immune system, or involving infection, cancer (especially hormone-sensitive tumours), urological problems such as an enlarged prostate or testicular mass, or insulin-dependent diabetes.
  • People with a known history of prostate problems, symptoms suggesting prostate disease, or a PSA (prostate-specific antigen) level of 4 ng/ml or higher measured in the past 12 months.
  • People with a history of, or current concerns about, a testicular mass.
  • People with a red blood cell concentration (hematocrit) above 50%.
  • People with a serious psychiatric illness.
  • People with active alcoholism.
  • People with a history of drug abuse in the past five years.
  • People with a BMI of 35 or higher.
  • People with a widespread skin condition that could affect how testosterone is absorbed through the skin (such as psoriasis), or a known skin reaction to alcohol.
  • People with a history of pituitary gland disease.
  • People with a cholesterol level above 300 mg/dl.
  • People who are currently receiving, or have received, experimental treatments within the six months before joining the study.
  • People with a history of positive test results for HIV 1 or 2, HTLV1, or syphilis (VDRL).
  • People with clinical signs of Lyme disease.
  • Men who are currently trying to conceive a child with their partner.
  • People currently taking the medication Finasteride.
  • People who, in the opinion of the examining neurologist, are not able to give informed consent or to understand and follow the study procedures.
  • People with any other contraindications identified by the manufacturer's exclusion criteria (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Omar A Raheem, MD, Assistant Professor, Urology

Phone: 504-756-4603

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Tulane University
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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).; 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).; Determine the change in self-reported erectile function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multip...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov