Nctid:
NCT00000175
Payload:
{"FullStudy"=>{"Rank"=>499138, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019964", "ConditionMeshTerm"=>"Mood Disorders"}, {"ConditionMeshId"=>"D000003072", "ConditionMeshTerm"=>"Cognition Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000019965", "ConditionAncestorTerm"=>"Neurocognitive Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6301", "ConditionBrowseLeafName"=>"Cognition Disorders", "ConditionBrowseLeafAsFound"=>"Cognition Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21835", "ConditionBrowseLeafName"=>"Mood Disorders", "ConditionBrowseLeafAsFound"=>"Mood Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21836", "ConditionBrowseLeafName"=>"Neurocognitive Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000013739", "InterventionMeshTerm"=>"Testosterone"}, {"InterventionMeshId"=>"D000004967", "InterventionMeshTerm"=>"Estrogens"}]}, "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"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8116", "InterventionBrowseLeafName"=>"Estrogens", "InterventionBrowseLeafAsFound"=>"PA", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M16509", "InterventionBrowseLeafName"=>"Testosterone", "InterventionBrowseLeafAsFound"=>"Observational Study", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4059", "InterventionBrowseLeafName"=>"Androgens", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9788", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}}, "StatusModule"=>{"OverallStatus"=>"Terminated", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2004", "CompletionDateStruct"=>{"CompletionDate"=>"June 2005", "CompletionDateType"=>"Anticipated"}, "LastUpdateSubmitDate"=>"December 10, 2009", "StudyFirstSubmitDate"=>"October 29, 1999", "StudyFirstSubmitQCDate"=>"October 29, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 11, 2009", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 1, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2005", "PrimaryCompletionDateType"=>"Anticipated"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Emotions", "Cognition", "Aging", "Memory"]}, "ConditionList"=>{"Condition"=>["Cognition Disorders", "Mood Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"9153164", "ReferenceType"=>"background", "ReferenceCitation"=>"Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s."}, {"ReferencePMID"=>"8037876", "ReferenceType"=>"background", "ReferenceCitation"=>"Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325."}, {"ReferencePMID"=>"9153163", "ReferenceType"=>"background", "ReferenceCitation"=>"Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.", "DetailedDescription"=>"Double-blind, placebo-controlled, crossover study investigating the effects of estrogen replacement and testosterone replacement on cognition and mood in older adults. Women who have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the uterine lining), and hysterectomized women will be given Premarin (estrogen only)."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"90 years", "MinimumAge"=>"65 years", "StdAgeList"=>{"StdAge"=>["Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Inclusion Criteria:\n\nWomen and men aged 65-90 who have not received hormone replacement for the last three months.\n\nExclusion Criteria:\n\nPrevious head injury with loss of consciousness for more than one hour.\nMen with a history of prostate cancer.\nMen on testosterone replacement within the past three months.\nWomen with a history of breast or uterine cancer.\nWomen on estrogen replacement within the past three months."}, "IdentificationModule"=>{"NCTId"=>"NCT00000175", "BriefTitle"=>"The Effects of Sex Hormones on Cognition and Mood in Older Adults", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Aging (NIA)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"IA0016"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Estrogen", "InterventionType"=>"Drug"}, {"InterventionName"=>"Testosterone", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"21224", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Gerontology Research Center"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Dr. Pauline Maki", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute on Aging, Gerontology Research Center"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Aging (NIA)", "LeadSponsorClass"=>"NIH"}}}}}}
