XYOSTED in Males with Multiple Sclerosis and Low Testosterone

study phasepsoriasis) or a known skin intolerance to alcohol.\n* Patients with history of pituitary disease.\n* Patients with a cholesterol level greater than 300 mg/dl.\n* Patients who are receiving or have received experimental therapies in the six months preceding enrollment.\n* Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).\n* Patients who have clinical evidence of Lyme disease.\n* Males who are trying to get their partner pregnant.\n* Patients on Finasteride\n* Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.\n* Any other contraindications according to the manufacturer's exclusion criteria.",

subjectspsoriasis) or a known skin intolerance to alcohol.\n* Patients with history of pituitary disease.\n* Patients with a cholesterol level greater than 300 mg/dl.\n* Patients who are receiving or have received experimental therapies in the six months preceding enrollment.\n* Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).\n* Patients who have clinical evidence of Lyme disease.\n* Males who are trying to get their partner pregnant.\n* Patients on Finasteride\n* Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.\n* Any other contraindications according to the manufacturer's exclusion criteria.",

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.

controlled"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.

regulatory approval"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.

research categoriespsoriasis) or a known skin intolerance to alcohol.\n* Patients with history of pituitary disease.\n* Patients with a cholesterol level greater than 300 mg/dl.\n* Patients who are receiving or have received experimental therapies in the six months preceding enrollment.\n* Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).\n* Patients who have clinical evidence of Lyme disease.\n* Males who are trying to get their partner pregnant.\n* Patients on Finasteride\n* Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.\n* Any other contraindications according to the manufacturer's exclusion criteria.",

intervention"name": "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).",

findings"whyStopped": "The study didn't receive funding to move forward.",

limitationsPlanned enrolment and endpoints are not findings.