The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.
Volunteers will be treated weekly with Xyosted 75 mg (given subcutaneously) for 3 months during which they will have 3 study visits, 6 weeks apart. The Baseline visit will include providing a blood sample, completing questionnaires, receiving training on the Xyosted auto-injector, and undergoing a rectal exam for participants 55 years and older. Visits 2 and 3 will also include collecting a blood sample and completing questionnaires. At Visit 3, the rectal exam for those age 55 years and older will be repeated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Self injection testosterone treatment
LSU Health Multispecilaity Clinics
New Orleans, Louisiana, United States
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).
Androgen Deficiency in the Aging Male (ADAM score) includes ten "Yes or No" questions, with an answer "Yes" to number 1 or 7 or if you answer "Yes" to more than 3 questions, you may have low Testosterone.
Time frame: Change from baseline to 12 weeks
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).
Sexual Health in Men (SHIM score) with a range of 1 to 25 with a higher number representing less erectile dysfunction.
Time frame: Change from baseline to 12 weeks
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).
Male Sexual Health Questionnaire short form (MSHQ-SF) with a range of 1 to 15 with a higher number representing better ejaculatory function, in addition to one bother/satisfaction question, scored 1 to 5 where the higher represents more bothersome.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported fatigue from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Modified Fatigue Impact Scale (MFIS).
Modified Fatigue Impact Scale (MFIS) with a range of 0 to 84 with a higher number representing greater impact of fatigue on a person's activities.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported depression from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Beck Depression Inventory (BDI).
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Beck Depression Inventory (BDI) with a range of 0 to 63 with a higher number representing higher level of depression.
Time frame: Change from baseline to 12 weeks
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).
Symbol Digit Modalities Test (SDMT) which provides a score for as many items as can be completed in 90 seconds (t-score calculated using age, sex and education normative data), with a higher score representing a better performance.
Time frame: Change from baseline to 12 weeks
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).
Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) with a range of 0 to 30 with a higher number representing worse cognitive function.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported overall quality of life from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the Multiple Sclerosis Quality of Life Scale (MSQOL-54).
Multiple Sclerosis Quality of Life Scale (MSQOL-54) which goes from 0 to 100 with a higher score indicating a better quality of life.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported urinary incontinence from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the American Urological Association Symptom Score (AUASS).
The American Urological Association Symptom Score (AUASS) with a range of 0 to 35 with a higher number representing more severe enlarged prostate symptoms.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported urinary incontinence after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using International Consultation on Incontinence Questionnaire short form (ICIQ-SF).
International Consultation on Incontinence Questionnaire short form (ICIQ-SF) with a range of 0 to 21 with a higher number representing greater impairment from incontinence.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported urinary incontinence from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Urogenital Distress Inventory short form (UDI-6).
Urogenital Distress Inventory short form (UDI-6) with a range of 0 to 100 with a higher number representing higher the disability.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported urinary incontinence from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using Incontinence Impact Questionnaire short form (IIQ-7).
Incontinence Impact Questionnaire short form (IIQ-7) with a range of 0 to 100 with a higher number representing greater impact by urinary incontinence on the person's life.
Time frame: Change from baseline to 12 weeks
Measure the change in self-reported pain from baseline to 12-weeks after 12 weeks of treatment with XYOSTED in males with Multiple Sclerosis with low testosterone using the McGill Pain Questionnaire (MPQ).
McGill Pain Questionnaire (MPQ) with a range of 0 to 78 with a higher number representing greater pain.
Time frame: Change from baseline to 12 weeks
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).
The serum levels of neurofilament-light chains (NF-L) with a higher level representing more neuro-axonal injury in the central nervous system.
Time frame: Change from baseline to 12 weeks