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Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
This trial will study the effects of testosterone treatment on various symptoms in older male MS patients with low testosterone levels.
- Low Testosterone
- Multiple Sclerosis
- Erectile Dysfunction
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- Men who are 18 years or older and have been diagnosed with multiple sclerosis.You are currently having sex.Your testosterone levels are consistently low on two early morning blood tests.You are not currently experiencing a relapse of your medical condition.You have concerns about sexual function and desire.Men who have been taking hormones for medical reasons in the past year.Men who have taken dehydroepiandrosterone (DHEA) in the last 3 months before the study.You have a history of prostate problems, symptoms of prostate issues, or high levels of a specific prostate-related protein (PSA) measured in the last year.You have a history of a lump or discomfort in your testicles.Your hematocrit level is higher than 50%.You have a serious mental illness.You are currently struggling with alcohol addiction.You have a body mass index (BMI) of 35 or higher.You have a history of pituitary disease.Your cholesterol level is higher than 300 mg/dl.You have taken any experimental treatments in the last six months.You have signs of Lyme disease.Men who are actively trying to have a baby with their partner.You are currently taking Finasteride.Men who are 18 years or older and have been diagnosed with multiple sclerosis.Your testosterone levels are consistently low in the morning.You are not currently experiencing a relapse of the condition being studied.Someone who is currently having sex.You are taking blood thinners or have serious medical conditions related to the heart, lungs, kidneys, liver, immune system, infections, cancer, or certain hormone-dependent tumors.You have a skin condition like psoriasis that could make it hard for your body to absorb the medication, or you are allergic to alcohol on your skin.You have concerns about your ability to have erections and your sex drive.You have used illegal drugs in the past five years.You have had positive tests for HIV, HTLV1, or VDRL.
- Group 1: Treatment open label arm
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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