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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
| Antares Pharma Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment open label arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector | Drug | Self injection testosterone treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Soliman, MD | Contact | 504-756-4603 | msoli2@lsuhsc.edu | |
| Jesus Lovera, MD | Contact | 504-568-4080 | jlover@lsuhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Omar A Raheem, MD | Assistant Professor, Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Multispecilaity Clinics | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24710799 | Background | Bove R, Musallam A, Healy BC, Raghavan K, Glanz BI, Bakshi R, Weiner H, De Jager PL, Miller KK, Chitnis T. Low testosterone is associated with disability in men with multiple sclerosis. Mult Scler. 2014 Oct;20(12):1584-92. doi: 10.1177/1352458514527864. Epub 2014 Apr 7. | |
| 20363715 | Background | Tehranipour M, Moghimi A. Neuroprotective effects of testosterone on regenerating spinal cord motoneurons in rats. J Mot Behav. 2010 May-Jun;42(3):151-5. doi: 10.1080/00222891003697921. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Single open label
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| 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). | Beck Depression Inventory (BDI) with a range of 0 to 63 with a higher number representing higher level of depression. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from baseline to 12 weeks |
| 17502467 | Background | Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683. |
| 28681643 | Background | Young CA, Tennant A; TONiC Study Group. Sexual functioning in multiple sclerosis: Relationships with depression, fatigue and physical function. Mult Scler. 2017 Aug 1;23(9):1268-1275. doi: 10.1177/1352458516675749. Epub 2016 Nov 1. |
| 27355400 | Background | Cunningham GR, Stephens-Shields AJ, Rosen RC, Wang C, Bhasin S, Matsumoto AM, Parsons JK, Gill TM, Molitch ME, Farrar JT, Cella D, Barrett-Connor E, Cauley JA, Cifelli D, Crandall JP, Ensrud KE, Gallagher L, Zeldow B, Lewis CE, Pahor M, Swerdloff RS, Hou X, Anton S, Basaria S, Diem SJ, Tabatabaie V, Ellenberg SS, Snyder PJ. Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels. J Clin Endocrinol Metab. 2016 Aug;101(8):3096-104. doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29. |
| 17048032 | Background | Yassin AA, Saad F. Treatment of sexual dysfunction of hypogonadal patients with long-acting testosterone undecanoate (Nebido). World J Urol. 2006 Dec;24(6):639-44. doi: 10.1007/s00345-006-0120-0. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |