{
  "FullStudy":{
    "Rank":217809,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516554",
          "OrgStudyIdInfo":{
            "OrgStudyId":"38486"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"812.14",
                "SecondaryIdType":"Other Grant/Funding Number",
                "SecondaryIdDomain":"Manitoba Medical Service Foundation"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Health Sciences Centre, Winnipeg, Manitoba",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients",
          "OfficialTitle":"A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2014",
          "OverallStatus":"Terminated",
          "WhyStopped":"Poor recruitment",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 4, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 8, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"James Marriott MD",
            "ResponsiblePartyInvestigatorTitle":"Assistant Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Health Sciences Centre, Winnipeg, Manitoba"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Health Sciences Centre, Winnipeg, Manitoba",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University of Manitoba",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Consortium of Multiple Sclerosis Centers",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Manitoba Medical Service Foundation",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Fatigue is one of the most frequent symptoms reported by multiple sclerosis (MS) patients and is often a significant source of disability. Unlike normal fatigue, multiple sclerosis related fatigue (MSRF) occurs independently of activity level, suggesting that it is due to dysfunction in the neural pathways that regulate the perception of energy although the precise cause is still not understood. While MSRF can be managed through lifestyle modifications and with drug treatment, these measures are commonly either ineffective or only partially effective.\n\nAdministration of the male sex hormone testosterone has been shown to improve energy levels in males with testosterone-deficiency states. Testosterone also reduces fatigue in patients with other medical conditions not associated with low testosterone levels, suggesting that this treatment may also be useful in symptomatic control of MSRF.\n\nThis proposed seven-month long clinical trial is designed to test the hypothesis that administration of oral testosterone tablets to male MS patients will result in an improvement of fatigue relative to the administration of placebo tablets. As fatigue is frequently reported by MS patients to be one of their most frustrating and disabling symptoms, any proven additional treatment option for MSRF would be beneficial in improving quality of life."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Multiple Sclerosis",
              "Fatigue"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Multiple Sclerosis",
              "Fatigue"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"3",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Testosterone undecanoate",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Testosterone undecanoate"
                  ]
                }
              },{
                "ArmGroupLabel":"Sugar pill",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Testosterone undecanoate",
                "InterventionDescription":"40 mg twice daily",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Testosterone undecanoate"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Andriol"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"placebo",
                "InterventionDescription":"twice daily",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Sugar pill"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in fatigue (measured with Modified Fatigue Impact Scale [M-FIS])",
                "PrimaryOutcomeTimeFrame":"baseline and 12 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in fatigue as measured on a visual analog scale (VAS)",
                "SecondaryOutcomeTimeFrame":"baseline and 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Quality of life as measured with the Aging Males' Symptoms (AMS) scale",
                "SecondaryOutcomeTimeFrame":"baseline and 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Neurological status as measured with the Expanded Disability Status Scale (EDSS)",
                "SecondaryOutcomeTimeFrame":"baseline and 12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Number of participants with , type and severity of adverse events",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll adult male (18—65 years old) patients are eligible. Patients over > 65 years will be excluded due to increased risk of prostatic hypertrophy or carcinoma in that age group.\nPatients must have diagnosis of MS using the 2005 revised McDonald Criteria.\nPatients must have an EDSS score ≤ 6.5.\nPatients must have a baseline MFIS score ≥ 45 (i.e.: those patients with fatigue).\nPatients must consent to participate in the study after a discussion of the potential risks and benefits of study participation with their physician. This consent must acknowledge that testosterone administration in MS is experimental and of no proven benefit.\nPatients must not be on any other agents to specifically treat MSRF (modafinil [Alertec®], amantadine, methylphenidate [Ritalin®, Ritalin SR®, Concerta®].\n\nExclusion Criteria:\n\nPrevious or current testosterone administration.\nAny Health Canada approved indication for testosterone administration.\nKnown hypersensitivity any component of the testosterone undecanoate (Andriol®) formulation including soy.\nHistory of relapse in the past 3 months.\nHistory of prostate hypertrophy or prostate carcinoma.\nHistory of breast cancer.\nModerate or severe prostate symptoms (International Prostate Symptom Score [IPSS] ≥ 8).\nAll patients ≥ 50 years old (or ≥ 40 years old if history of prostate cancer/prostate hypertrophy in a first-degree relative or if African-Canadian) will be require a urological assessment including prostate specific antigen (PSA) and digital rectal exam (DRE). Such patients will be excluded if they have a high PSA level or if they have a palpable prostate nodule. Abnormal PSA levels will be determined using standard age-specific cut-off levels.\nOther serious medical comorbidities including: any other cancer or myelodysplastic syndrome, anemia or polycythemia of any cause, vascular risk factors (including hypertension, dyslipidemia, myocardial infarction, stroke, peripheral vascular disease, atrial fibrillation, other hypercoaguable state or thrombotic risk factor), serious kidney or liver disease, diabetes, obstructive sleep apnea or serious psychiatric disease.\nHistory of current alcohol misuse.\nRecent major surgery.\nUse of the following medications whose metabolism may be altered by TT: warfarin, corticosteroids, propranolol, cyclosporine or St. John's Wort.81\nPatients on cyclophosphamide or mitoxantrone (Novantrone®) chemotherapy for MS will be excluded. Patients on other approved disease-modifying therapies for MS (interferon-β1a [Avonex®, Rebif®], interferon-β1b [Betaseron®], glatiramer acetate [Copaxone®] and natalizumab [Tysabri®]) can participate in this trial provided they have been on these therapies for at least six months at a stable dose.",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"James J Marriott, MD",
                "OverallOfficialAffiliation":"University of Manitoba",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Health Sciences Centre",
                "LocationCity":"Winnipeg",
                "LocationState":"Manitoba",
                "LocationZip":"R3A1R9",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000008777",
                "InterventionMeshTerm":"Methyltestosterone"
              },{
                "InterventionMeshId":"D000013739",
                "InterventionMeshTerm":"Testosterone"
              },{
                "InterventionMeshId":"C000010792",
                "InterventionMeshTerm":"Testosterone undecanoate"
              },{
                "InterventionMeshId":"C000004648",
                "InterventionMeshTerm":"Testosterone enanthate"
              },{
                "InterventionMeshId":"C000016131",
                "InterventionMeshTerm":"Testosterone 17 beta-cypionate"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000728",
                "InterventionAncestorTerm":"Androgens"
              },{
                "InterventionAncestorId":"D000006728",
                "InterventionAncestorTerm":"Hormones"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018931",
                "InterventionAncestorTerm":"Antineoplastic Agents, Hormonal"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000045930",
                "InterventionAncestorTerm":"Anabolic Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M10334",
                "InterventionBrowseLeafName":"Methyltestosterone",
                "InterventionBrowseLeafAsFound":"Testosterone Undecanoate",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M15092",
                "InterventionBrowseLeafName":"Testosterone",
                "InterventionBrowseLeafAsFound":"Testosterone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M231009",
                "InterventionBrowseLeafName":"Testosterone undecanoate",
                "InterventionBrowseLeafAsFound":"Testosterone Undecanoate",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M231022",
                "InterventionBrowseLeafName":"Testosterone enanthate",
                "InterventionBrowseLeafAsFound":"Testosterone Undecanoate",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M243057",
                "InterventionBrowseLeafName":"Testosterone 17 beta-cypionate",
                "InterventionBrowseLeafAsFound":"Testosterone Undecanoate",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2640",
                "InterventionBrowseLeafName":"Androgens",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19550",
                "InterventionBrowseLeafName":"Antineoplastic Agents, Hormonal",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M24192",
                "InterventionBrowseLeafName":"Anabolic Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009103",
                "ConditionMeshTerm":"Multiple Sclerosis"
              },{
                "ConditionMeshId":"D000012598",
                "ConditionMeshTerm":"Sclerosis"
              },{
                "ConditionMeshId":"D000005221",
                "ConditionMeshTerm":"Fatigue"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000020278",
                "ConditionAncestorTerm":"Demyelinating Autoimmune Diseases, CNS"
              },{
                "ConditionAncestorId":"D000020274",
                "ConditionAncestorTerm":"Autoimmune Diseases of the Nervous System"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000003711",
                "ConditionAncestorTerm":"Demyelinating Diseases"
              },{
                "ConditionAncestorId":"D000001327",
                "ConditionAncestorTerm":"Autoimmune Diseases"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M10643",
                "ConditionBrowseLeafName":"Multiple Sclerosis",
                "ConditionBrowseLeafAsFound":"Multiple Sclerosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13998",
                "ConditionBrowseLeafName":"Sclerosis",
                "ConditionBrowseLeafAsFound":"Sclerosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6947",
                "ConditionBrowseLeafName":"Fatigue",
                "ConditionBrowseLeafAsFound":"Fatigue",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3210",
                "ConditionBrowseLeafName":"Autoimmune Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20682",
                "ConditionBrowseLeafName":"Demyelinating Autoimmune Diseases, CNS",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20678",
                "ConditionBrowseLeafName":"Autoimmune Diseases of the Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5492",
                "ConditionBrowseLeafName":"Demyelinating Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}