Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)
Tulane University
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.
Description
Volunteers will be treated weekly with Xyosted 75 mg (given subcutaneously) for 3 months during which they will have 3 study visits, 6 weeks apart. The Baseline visit will include providing a blood sample, completing questionnaires, receiving training on the Xyosted auto-injector, and undergoing a rectal exam for participants 55 years and older. Visits 2 and 3 will also include collecting a blood sample and completing questionnaires. At Visit 3, the rectal exam for those age 55 years and older will be repeated.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 s…
Interventions
- DrugXYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
Self injection testosterone treatment
Location
- LSU Health Multispecilaity ClinicsNew Orleans, Louisiana