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Androgen Replacement Therapy

Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Q: 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/erectile-dysfunction">erectile dysfunction</a> and the 6 studies actively accepting volunteers for XYOSTED 75 milligram (mg) injections via a 0.5 ML Auto-Injector device.

Q: 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 <a href="https://www.withpower.com/clinical-trials/erectile-dysfunction">erectile dysfunction</a> are still actively enrolling candidates; alongside 6 clinical experiments enlisting individuals who require XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector treatments.

Q: 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 <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">Multiple Sclerosis</a> and low <a href="https://www.withpower.com/clinical-trials/testosterone">testosterone</a>, as measured by the Androgen Deficiency in the Aging Male (ADAM) score. Secondary outcomes include gauging changes to <a href="https://www.withpower.com/clinical-trials/pain">pain</a> 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> is hosting most of these studies; however, 7 distinct locations are involved overall.

LSU Health Multispecilaity Clinics, New Orleans, LA

Targeting 3 different conditionsXYOSTED 75 milligram (mg) in 0.5 ML Auto-InjectorPhase 4Waitlist AvailableLed by Omar A Raheem, MDResearch Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upchange from baseline to 12 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Study Summary

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

Eligible Conditions

Low Testosterone
Multiple Sclerosis
Erectile Dysfunction

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

Men who are 18 years or older and have been diagnosed with multiple sclerosis.

Select...

Your testosterone levels are consistently low in the morning.

Select...

You are not currently experiencing a relapse of the condition being studied.

Select...

Someone who is currently having sex.

Select...

You have concerns about your ability to have erections and your sex drive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 weeks

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).

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor

109 Previous Clinical Trials

219,424 Total Patients Enrolled

Louisiana State University Health Sciences Center in New OrleansOTHER

112 Previous Clinical Trials

42,971 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