Nctid:
NCT00001306
Payload:
{"FullStudy"=>{"Rank"=>473130, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000047928", "ConditionMeshTerm"=>"Premature Birth"}, {"ConditionMeshId"=>"D000007246", "ConditionMeshTerm"=>"Infertility"}, {"ConditionMeshId"=>"D000016649", "ConditionMeshTerm"=>"Primary Ovarian Insufficiency"}, {"ConditionMeshId"=>"D000008594", "ConditionMeshTerm"=>"Menopause, Premature"}, {"ConditionMeshId"=>"D000001327", "ConditionMeshTerm"=>"Autoimmune Diseases"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007752", "ConditionAncestorTerm"=>"Obstetric Labor, Premature"}, {"ConditionAncestorId"=>"D000007744", "ConditionAncestorTerm"=>"Obstetric Labor Complications"}, {"ConditionAncestorId"=>"D000011248", "ConditionAncestorTerm"=>"Pregnancy Complications"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000010049", "ConditionAncestorTerm"=>"Ovarian Diseases"}, {"ConditionAncestorId"=>"D000000291", "ConditionAncestorTerm"=>"Adnexal Diseases"}, {"ConditionAncestorId"=>"D000005831", "ConditionAncestorTerm"=>"Genital Diseases, Female"}, {"ConditionAncestorId"=>"D000052776", "ConditionAncestorTerm"=>"Female Urogenital Diseases"}, {"ConditionAncestorId"=>"D000006058", "ConditionAncestorTerm"=>"Gonadal Disorders"}, {"ConditionAncestorId"=>"D000004700", "ConditionAncestorTerm"=>"Endocrine System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9980", "ConditionBrowseLeafName"=>"Infertility", "ConditionBrowseLeafAsFound"=>"Infertility", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M25559", "ConditionBrowseLeafName"=>"Premature Birth", "ConditionBrowseLeafAsFound"=>"Premature", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11267", "ConditionBrowseLeafName"=>"Menopause, Premature", "ConditionBrowseLeafAsFound"=>"Premature Ovarian Failure", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M18710", "ConditionBrowseLeafName"=>"Primary Ovarian Insufficiency", "ConditionBrowseLeafAsFound"=>"Premature Ovarian Failure", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3599", "ConditionBrowseLeafName"=>"Amenorrhea", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4319", "ConditionBrowseLeafName"=>"Autoimmune Diseases", "ConditionBrowseLeafAsFound"=>"Autoimmune Diseases", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10462", "ConditionBrowseLeafName"=>"Obstetric Labor, Premature", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10454", "ConditionBrowseLeafName"=>"Obstetric Labor Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13817", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26783", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8089", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2877", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12662", "ConditionBrowseLeafName"=>"Ovarian Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3333", "ConditionBrowseLeafName"=>"Adnexal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8633", "ConditionBrowseLeafName"=>"Genital Diseases, Female", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8853", "ConditionBrowseLeafName"=>"Gonadal Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7552", "ConditionBrowseLeafName"=>"Endocrine System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T6036", "ConditionBrowseLeafName"=>"Menopause", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Gland and Hormone Related Diseases", "ConditionBrowseBranchAbbrev"=>"BC19"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M13811", "InterventionBrowseLeafName"=>"Prednisone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8737", "InterventionBrowseLeafName"=>"Glucocorticoids", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Inflammatory Agents", "InterventionBrowseBranchAbbrev"=>"Infl"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"33"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"July 10, 1992"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 12, 2011", "CompletionDateStruct"=>{"CompletionDate"=>"December 12, 2011"}, "LastUpdateSubmitDate"=>"June 30, 2017", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"July 2, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Infertility", "Ovulation", "Autoimmune", "Follicle", "Menopause", "Biopsy", "Glucocorticoids", "Premature Ovarian Failure", "Amenorrhea", "Ovarian Failure", "POF"]}, "ConditionList"=>{"Condition"=>["Autoimmune Disease", "Infertility", "Premature Ovarian Failure"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"9175911", "ReferenceType"=>"background", "ReferenceCitation"=>"Maity R, Caspi RR, Nair S, Rizzo LV, Nelson LM. Murine postthymectomy autoimmune oophoritis develops in association with a persistent neonatal-like Th2 response. Clin Immunol Immunopathol. 1997 Jun;83(3):230-6. doi: 10.1006/clin.1997.4338."}, {"ReferencePMID"=>"7883837", "ReferenceType"=>"background", "ReferenceCitation"=>"Anasti JN, Flack MR, Froehlich J, Nelson LM. The use of human recombinant gonadotropin receptors to search for immunoglobulin G-mediated premature ovarian failure. J Clin Endocrinol Metab. 1995 Mar;80(3):824-8. doi: 10.1210/jcem.80.3.7883837."}, {"ReferencePMID"=>"9166320", "ReferenceType"=>"background", "ReferenceCitation"=>"Kim TJ, Anasti JN, Flack MR, Kimzey LM, Defensor RA, Nelson LM. Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1997 May;89(5 Pt 1):777-9. doi: 10.1016/s0029-7844(97)00077-x."}]}}, "DescriptionModule"=>{"BriefSummary"=>"No therapy for infertile patients with premature ovarian failure has been proven effective. Some anecdotal reports have suggested that high dose, long term prednisone (steroid) therapy may be useful in treating autoimmune ovarian failure. However, prednisone, when used in high-doses for long periods of time has substantial side effects, including aseptic necrosis of bone where portions of bone die without the presence of infection and are surrounded by healthy tissue. Aseptic necrosis of bone often requires major surgical treatment. Even with this known level of risk, patients with premature ovarian failure are being treated based on this anecdotal evidence.\n\nThis study will test the hypothesis that a lower risk therapy (alternate-day, lower dose, shorter-term prednisone) will cause a remission of autoimmune ovarian failure. There is no reliable blood test to identify patients who have premature ovarian failure. Therefore, all patients must undergo a laparoscopic ovarian biopsy to confirm the presence of an auto immune reaction in the ovaries (autoimmune oophoritis). Laparoscopy is a surgical procedure that allows doctors to explore the abdomen using a camera-like device called a laparoscope. The procedure has been used clinically by some reproductive endocrinologists to identify patients with premature ovarian failure who have an autoimmune mechanism for the disorder.\n\nThe treatment will be deemed successful based on the return of ovulation as determined by weekly serum progesterone levels.", "DetailedDescription"=>"Autoimmune oophoritis is a distinct clinical entity and a known cause of premature ovarian failure. It is characterized by the presence of circulating adrenal antibodies. No therapy for infertile patients with premature ovarian failure due to autoimmune oophoritis has been proven effective by prospective controlled study. Anecdotal reports have suggested that high-dose, long-term prednisone therapy may be useful in treating autoimmune ovarian failure. However, prednisone, when used in high-dose for a long-term has substantial side effects, including aseptic necrosis of bone requiring major surgical intervention. Despite this risk, patients with premature ovarian failure are being treated based on this anecdotal evidence. We are aware of two patients with premature ovarian failure who developed aseptic necrosis of bone on high-dose, long-term prednisone therapy administered elsewhere.\n\nThis protocol will test the hypothesis that a lower risk therapy (alternate-day, lower dose, shorter-term prednisone) will induce remission of ovarian failure caused by autoimmune oophoritis. The protocol will use a double-masked, placebo-controlled design. Patients with premature ovarian failure who have serologic evidence of steroidogenic cell autoimmunity will be candidates. Successful outcome will be defined as a return of ovulation as determined by weekly serum progesterone levels. The hypothesis that short-term, alternate-day prednisone therapy restores ovulation will be tested with an equality of proportions test comparing the proportion of patients who ovulate during placebo with the proportion of patients who ovulate during prednisone therapy."}, "EligibilityModule"=>{"Gender"=>"Female", "MaximumAge"=>"39 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION/EXCLUSION CRITERIA:\n\nWomen 18 to 39 years of age with premature ovarian failure who meet the following requirements will be candidates for the study:\n\nAt least a four month history of amenorrhea not due to pregnancy,\n\nClearly elevated gonadotropins with a serum FSH greater than or equal to 40 IU/L on two separate occasions at least one month apart,\n\nPositive adrenal or ovarian antibodies demonstrated by indirect immuno-fluorescence using monkey tissue as substrate or other laboratory evidence of steroidogenic cell autoimmunity such as the presence of antibodies against 21-hydroxylase,\n\nNo evidence for genetic, metabolic, toxic, or iatrogenic cause of the ovarian failure,\n\nNo medical contraindication to glycocorticoid therapy,\n\nNo glycocorticoid therapy taken in the past year (patients on appropriate replacement therapy for Addison's disease are not excluded),\n\nNo medical contraindication to pregnancy."}, "IdentificationModule"=>{"NCTId"=>"NCT00001306", "BriefTitle"=>"Steroid Therapy in Autoimmune Premature Ovarian Failure", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Autoimmune Premature Ovarian Failure: A Controlled Trial of Alternate-Day Prednisone Therapy", "OrgStudyIdInfo"=>{"OrgStudyId"=>"920223"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"92-CH-0223"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", "LeadSponsorClass"=>"NIH"}}}}}}
