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
Qualifiers
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
Treatments tested in this trial
- XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Tulane University
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborator
Antares Pharma Inc.
Collaborator
Source ClinicalTrials.gov