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Androgen Replacement Therapy

Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Phase 4
Waitlist Available
Led By Omar A Raheem, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexually active
Low testosterone (<300 ng/dl) on two successive blood draws before 9:00 am
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 weeks
Awards & highlights

Study Summary

This trial will study the effects of testosterone treatment on various symptoms in older male MS patients with low testosterone levels.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of XYOSTED may include skin reactions at the injection site, changes in mood or energy levels, increased red blood cell count which can lead to complications like clotting disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am sexually active.
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My testosterone levels were below 300 ng/dl on two morning tests.
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I am a man over 18 with a confirmed diagnosis of multiple sclerosis.
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I am willing to complete tests, questionnaires, and attend all scheduled visits.
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My testosterone levels were below 300 ng/dl on two morning tests.
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I am a man over 18 with a confirmed diagnosis of multiple sclerosis.
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My condition is stable and not currently worsening.
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I am not currently experiencing a relapse.
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I am experiencing issues with sexual function and desire.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome 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).
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).
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).
Secondary outcome measures
Measure the change in Multiple Sclerosis lesions, indirectly from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the serum levels of neurofilament-light chains (NF-L).
Measure the change in cognitive function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ).
Measure the change in cognitive function from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Symbol Digit Modalities Test (SDMT).
+8 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,482 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansOTHER
113 Previous Clinical Trials
44,171 Total Patients Enrolled
Antares Pharma Inc.Industry Sponsor
10 Previous Clinical Trials
1,214 Total Patients Enrolled

Media Library

XYOSTED (Androgen Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04601233 — Phase 4
Low Testosterone Research Study Groups: Treatment open label arm
Low Testosterone Clinical Trial 2023: XYOSTED Highlights & Side Effects. Trial Name: NCT04601233 — Phase 4
XYOSTED (Androgen Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601233 — Phase 4
Low Testosterone Patient Testimony for trial: Trial Name: NCT04601233 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the FDA's blessing in place for XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector?

"Data from Phase 4 trials has demonstrated the safety of XYOSTED auto-injectors at 75mg, so this particular medication was given a score of 3."

Answered by AI

Are researchers actively seeking volunteers for this clinical evaluation?

"This clinical trial is not currently enrolling patients. It was initially listed on December 1st 2022 before being last updated July 19th 2022. Alternativley, those seeking to participate in medical trials can look into the 614 studies that are presently searching for participants with erectile dysfunction and the 6 studies actively accepting volunteers for XYOSTED 75 milligram (mg) injections via a 0.5 ML Auto-Injector device."

Answered by AI

How many test subjects are actively participating in this research endeavor?

"This specific trial is no longer recruiting participants. It was initiated on the 12th of December 2022, and last updated during July 19th 2022. If patients are looking for alternative studies to join, 614 trials related to erectile dysfunction are still actively enrolling candidates; alongside 6 clinical experiments enlisting individuals who require XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector treatments."

Answered by AI

What are the projected conclusions of this particular experiment?

"The primary endpoint of this study is to assess the alteration in self-reported erectile function over a 12 week period following treatment with XYOSTED for males suffering from Multiple sclerosis and low testosterone, as measured by the Androgen Deficiency in the Aging Male (ADAM) score. Secondary outcomes include gauging changes to pain sensitivity via McGill Pain Questionnaire (MPQ), Urogential Distress Inventory short form (UDI-6) to measure urinary incontinence, and Incontinence Impact Questionnaire short form (IIQ-7) which evaluates how much impact urinary incontinence has on one's life."

Answered by AI

What prior research regarding XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector has been conducted?

"Presently, there are 6 ongoing trials for XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector with none of them being at the third phase yet. Galveston Texas is hosting most of these studies; however, 7 distinct locations are involved overall."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Mississippi
Other
How old are they?
18 - 65
What site did they apply to?
LSU Health Multispecilaity Clinics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have ed and ms and looking to help in trail so me and others might have other options in future.
PatientReceived no prior treatments
Recent research and studies
~13 spots leftby Dec 2024