Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04601233
• Other study ID #: 1288
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Tulane University
• Contact: Michael Soliman, MD
• Phone: 504-756-4603
• Email: msoli2[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Not in an intercurrent relapse.

• Sexually active.

• Have subjective complaints about erectile function and libido.

• Must be willing and able to get labs drawn, complete questionnaires (BDI, MFIS, MSNQ, SDMT, MSQOL, ADAM, AUASS, SHIM, MSHQ, ICIQ, UDI, IIQ, MPQ) and commit to site visits schedule.

Exclusion Criteria:

• Males unable to fulfill the above criteria and all female patients.

• Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.

• Males who have taken dehydroepiandrosterone (DHEA) during the 3 months prior to study.

• Patients who are taking anticoagulants or have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), urologic disease especially prostatic hypertrophy/nodules and testicular mass, or insulin-dependent diabetes.

• Patients with an abnormal prostate as evidenced by known history of prostatic disease, symptoms suggestive of prostatic disease or elevated levels of prostatic specific antigen (PSA 4 ng/ml or higher) measured within the last 12 months.

• Patients with history or complaint of testicular mass.

• Patients with hematocrit greater than 50%

• Patients with major psychiatric illness

• Patients with active alcoholism.

• Patients with a history of drug abuse within the past five years.

• 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.

• Patients with history of pituitary disease.

• Patients with a cholesterol level greater than 300 mg/dl.

• Patients who are receiving or have received experimental therapies in the six months preceding enrollment.

• Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).

• Patients who have clinical evidence of Lyme disease.

• Males who are trying to get their partner pregnant.

• Patients on Finasteride

• Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.

• Any other contraindications according to the manufacturer's exclusion criteria.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Multiple Sclerosis
• Sclerosis
• Testosterone Deficiency

Intervention

Drug:
• XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
Self injection testosterone treatment

Locations

Country	Name	City	State
United States	LSU Health Multispecilaity Clinics	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	Antares Pharma Inc., Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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