Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis

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

WithdrawnPhase 4MS (type not specified)NCT04601233

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: The study didn't receive funding to move forward.

What was tested

Treatment tested

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

What it measured

Main measures

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual function

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual function

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Other measures (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

    Fatigue

  • 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

    Mood and sleep

  • 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

    Thinking and memory

  • 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

    Thinking and memory

  • 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

    Quality of life (reported by participants)

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual function

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual function

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual function

  • 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).

    Change from baseline to 12 weeks

    Bladder, bowel and sexual function

  • 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).

    Change from baseline to 12 weeks

    Pain

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jun 2026

    2. Main results due

      Sept 2026

    3. Finished

      Sept 2026

    Assembled by software from public sources.