Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

NCT04601233 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 1288
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Erectile Dysfunction; Testosterone Deficiency

Keywords

Multiple Sclerosis; Erectile Dysfunction; Testosterone Deficiency

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• 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).

  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).

  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).

  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).

  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).

  Change from baseline to 12 weeks

Study Arms (1)

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.

Drug: XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector

Interventions

XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector DRUG

Self injection testosterone treatment

Treatment open label arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• Antares Pharma Inc.: collaborator

Study Sites (1)

LSU Health Multispecilaity Clinics

New Orleans, Louisiana, 70112, United States

Location

Related 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.

  PMID: 24710799 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.

  PMID: 20363715 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.

  PMID: 17502467 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.

  PMID: 28681643 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.

  PMID: 27355400 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.

  PMID: 17048032 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Omar A Raheem, MD

  Assistant Professor, Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Soliman, MD

CONTACT

504-756-4603; msoli2@lsuhsc.edu

Jesus Lovera, MD

CONTACT

504-568-4080; jlover@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single open label

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 23, 2020
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)