XYOSTED in Males with Multiple Sclerosis and Low Testosterone
A planned study intended to evaluate the effects of XYOSTED on erectile function in men with Multiple Sclerosis and low testosterone was withdrawn due to lack of funding. No results or findings were reported as the study did not progress.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
Why it matters
This study was designed to address sexual health issues in a specific population, highlighting the importance of addressing testosterone deficiency in men with Multiple Sclerosis. The absence of results sheds light on the challenges in conducting research for this group.
What this does not prove
Since the study was withdrawn, there are no findings to analyze or interpret, which limits understanding of the potential effects of XYOSTED on erectile function in the specified population.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
- Trial registrationTestosterone Treatment for Erectile Dysfunction and Multiple Sclerosis ↗
Supporting passages (6)
randomized"eligibilityCriteria": "Inclusion Criteria:\n\n* Males, age 18 years and older, with a definite diagnosis of multiple sclerosis.\n* Low testosterone (\\<300 ng/dl) on two successive blood draws before 9:00 am\n* Not in an intercurrent relapse.\n* Sexually active.\n* Have subjective complaints about erectile function and libido.\n* 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.\n\nExclusion Criteria:\n\n* Males unable to fulfill the above criteria and all female patients.\n* 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.\n* Males who have taken dehydroepiandrosterone (DHEA) during the 3 months prior to study.\n* 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.\n* 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.\n* Patients with history or complaint of testicular mass.\n* Patients with hematocrit greater than 50%\n* Patients with major psychiatric illness\n* Patients with active alcoholism.\n* Patients with a history of drug abuse within the past five years.\n* Patients with BMI ≥ 35\n* Patients with generalized skin disease that may affect absorption of testosterone (e.g.
intervention"Drug: XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector"
primary endpoint"measure": "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).",
follow up"timeFrame": "Change from baseline to 12 weeks"
findingsNo results are posted.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.