What is the mechanism of action of this treatment?

Testosterone replacement therapy (TRT) is the most common treatment for low testosterone. It works by supplementing the body with exogenous testosterone through gels, injections, or patches to restore normal hormone levels. This is crucial for patients as it helps alleviate symptoms such as fatigue, depression, cognitive decline, and sexual dysfunction, and supports overall health by maintaining bone density, muscle mass, mood, and sexual function.

What side effects are associated with this type of intervention?

Common treatments for low testosterone, such as testosterone supplementation, can have several side effects. These include an increased risk of cardiovascular events, such as heart attacks and strokes, as well as potential increases in noncalcified coronary artery plaque volume. Sexual dysfunction, including decreased libido and erectile dysfunction, may also occur. Other side effects can include mood changes, such as improved or worsened depressive symptoms, and physical changes like increased muscle mass or changes in body composition. It is important for patients to discuss these potential risks and benefits with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several testosterone replacement therapies for the treatment of low testosterone levels. These include transdermal patches, gels, and intramuscular injections. Transdermal patches and gels are commonly used for their ease of application and steady hormone delivery, while intramuscular injections are preferred for their longer dosing intervals. These treatments aim to restore normal testosterone levels and improve symptoms such as fatigue, depression, and cognitive function.

What other types of research exist?

Promising novel alternatives to testosterone supplementation for low testosterone patients include: 1) Clomiphene Citrate, which stimulates endogenous testosterone production by blocking estrogen receptors in the brain, leading to increased gonadotropin release. 2) Anastrozole, an aromatase inhibitor that prevents the conversion of testosterone to estrogen, thereby increasing testosterone levels. 3) Selective Androgen Receptor Modulators (SARMs), which are being investigated for their ability to selectively stimulate androgen receptors in muscle and bone tissues without significant side effects. These alternatives have shown potential in clinical trials and may offer effective treatment options with fewer risks compared to traditional testosterone therapy.

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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

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 weeks

Awards & highlights

Summary

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.

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is 35 or higher.

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

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

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I am currently taking Finasteride.

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

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I have a history of pituitary gland disease.

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I show signs of having Lyme disease.

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

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

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

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

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 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Testosterone replacement therapy (TRT) is the most common treatment for low testosterone. It works by supplementing the body with exogenous testosterone through gels, injections, or patches to restore normal hormone levels. This is crucial for patients as it helps alleviate symptoms such as fatigue, depression, cognitive decline, and sexual dysfunction, and supports overall health by maintaining bone density, muscle mass, mood, and sexual function.

Hormonal changes and their impact on cognition and mental health of ageing men.Androgen replacement therapy in the aging male.Increasing testosterone levels and effects on cognitive functions in elderly men and women: a review.