Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 7 October 2024
• Main ID: NCT04601233
• Date of registration: 02/10/2020
• Prospective Registration: Yes
• Primary sponsor: Tulane University
• Public title: Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
• Scientific title: Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)
• Date of first enrolment: June 2025
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04601233
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Omar A Raheem, MD
• Affiliation: Assistant Professor, Urology

• Name: Michael Soliman, MD

• Name: Michael Soliman, MD

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Testosterone Deficiency

Erectile Dysfunction

Multiple Sclerosis

Intervention(s)

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

Primary Outcome(s)

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). [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). [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). [Time Frame: Change from baseline to 12 weeks]

Secondary Outcome(s)

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). [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). [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). [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). [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). [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). [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). [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). [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). [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). [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). [Time Frame: Change from baseline to 12 weeks]

Secondary ID(s)

1288

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Antares Pharma Inc.

Louisiana State University Health Sciences Center in New Orleans