Phase 4Withdrawn
Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)
- Sponsor
- Tulane University (Academic or other)
- Conditions
- Multiple Sclerosis; Erectile Dysfunction; Testosterone Deficiency
- Interventions
- XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector
- Ages
- adults, older adults
- Registry
- NCT04601233
From the registry
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.
Primary outcomes
- 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).
- 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).
- 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).