Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorTulane University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
DrugSelf injection testosterone treatment
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment open label armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline to 12 weeks2
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.
Time frame
Change from baseline to 12 weeks3
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.
Time frame
Change from baseline to 12 weeksSecondary outcomes
1
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.
Time frame
Change from baseline to 12 weeks2
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.
Time frame
Change from baseline to 12 weeks3
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.
Time frame
Change from baseline to 12 weeks4
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.
Time frame
Change from baseline to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tulane University
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborator
Antares Pharma Inc.
Collaborator
Source ClinicalTrials.gov
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