{ "FullStudy":{ "Rank":217591, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519401", "OrgStudyIdInfo":{ "OrgStudyId":"000102010" }, "Organization":{ "OrgFullName":"Catholic University of the Sacred Heart", "OrgClass":"OTHER" }, "BriefTitle":"Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.", "OfficialTitle":"Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study." }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2010" }, "CompletionDateStruct":{ "CompletionDate":"July 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 23, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 26, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Maurizio Guido", "ResponsiblePartyInvestigatorTitle":"medical doctor", "ResponsiblePartyInvestigatorAffiliation":"Catholic University of the Sacred Heart" }, "LeadSponsor":{ "LeadSponsorName":"Catholic University of the Sacred Heart", "LeadSponsorClass":"OTHER" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).\n\nThe objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Polycystic Ovary Syndrome", "Estro-progestin Drugs" ] }, "KeywordList":{ "Keyword":[ "PCOS", "drospirenone ethinylestradiol", "androgens", "metabolism" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"3 mg drospirenone and 20 µg ethinyl-estradiol", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol" ] } },{ "ArmGroupLabel":"3 mg drospirenone and 30 µg ethinyl-estradiol", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"3 mg drospirenone and 20 µg ethinyl-estradiol", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "3 mg drospirenone and 20 µg ethinyl-estradiol" ] } },{ "InterventionType":"Drug", "InterventionName":"3 mg drospirenone and 30 µg ethinyl-estradiol", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "3 mg drospirenone and 30 µg ethinyl-estradiol" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women", "PrimaryOutcomeDescription":"hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile", "PrimaryOutcomeTimeFrame":"twelve months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nnormal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.\n\nExclusion Criteria:\n\npregnancy\npast history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension\nsignificant liver or renal impairment\nother hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)\nneoplasms\nunstable mental illness", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"35 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Catholic University of Sacred Heart", "LocationCity":"Rome", "LocationZip":"00168", "LocationCountry":"Italy" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"24105072", "ReferenceType":"derived", "ReferenceCitation":"Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: a randomized study. J Endocrinol Invest. 2013 Sep;36(8):636-41." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000035144", "InterventionMeshTerm":"Drospirenone" },{ "InterventionMeshId":"C000074283", "InterventionMeshTerm":"Estradiol 3-benzoate" },{ "InterventionMeshId":"C000007630", "InterventionMeshTerm":"Estradiol 17 beta-cypionate" },{ "InterventionMeshId":"D000004958", "InterventionMeshTerm":"Estradiol" },{ "InterventionMeshId":"C000008958", "InterventionMeshTerm":"Polyestradiol phosphate" },{ "InterventionMeshId":"D000004997", "InterventionMeshTerm":"Ethinyl Estradiol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000004967", "InterventionAncestorTerm":"Estrogens" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000003270", "InterventionAncestorTerm":"Contraceptive Agents" },{ "InterventionAncestorId":"D000012102", "InterventionAncestorTerm":"Reproductive Control Agents" },{ "InterventionAncestorId":"D000003271", "InterventionAncestorTerm":"Contraceptive Agents, Female" },{ "InterventionAncestorId":"D000000451", "InterventionAncestorTerm":"Mineralocorticoid Receptor Antagonists" },{ "InterventionAncestorId":"D000006727", "InterventionAncestorTerm":"Hormone Antagonists" },{ "InterventionAncestorId":"D000062865", "InterventionAncestorTerm":"Diuretics, Potassium Sparing" },{ "InterventionAncestorId":"D000004232", "InterventionAncestorTerm":"Diuretics" },{ "InterventionAncestorId":"D000045283", "InterventionAncestorTerm":"Natriuretic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M204621", "InterventionBrowseLeafName":"Estradiol 3-benzoate", "InterventionBrowseLeafAsFound":"Estradiol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M237310", "InterventionBrowseLeafName":"Estradiol 17 beta-cypionate", "InterventionBrowseLeafAsFound":"Estradiol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M6691", "InterventionBrowseLeafName":"Estradiol", "InterventionBrowseLeafAsFound":"Estradiol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M242995", "InterventionBrowseLeafName":"Polyestradiol phosphate", "InterventionBrowseLeafAsFound":"Estradiol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M6728", "InterventionBrowseLeafName":"Ethinyl Estradiol", "InterventionBrowseLeafAsFound":"Ethinyl estradiol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M215415", "InterventionBrowseLeafName":"Drospirenone", "InterventionBrowseLeafAsFound":"Drospirenone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M6699", "InterventionBrowseLeafName":"Estrogens", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5077", "InterventionBrowseLeafName":"Contraceptive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2378", "InterventionBrowseLeafName":"Mineralocorticoid Receptor Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10454", "InterventionBrowseLeafName":"Mineralocorticoids", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5994", "InterventionBrowseLeafName":"Diuretics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M28612", "InterventionBrowseLeafName":"Diuretics, Potassium Sparing", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"NaAg", "InterventionBrowseBranchName":"Natriuretic Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011085", "ConditionMeshTerm":"Polycystic Ovary Syndrome" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004194", "ConditionAncestorTerm":"Disease" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000010048", "ConditionAncestorTerm":"Ovarian Cysts" },{ "ConditionAncestorId":"D000003560", "ConditionAncestorTerm":"Cysts" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000010049", "ConditionAncestorTerm":"Ovarian Diseases" },{ "ConditionAncestorId":"D000000291", "ConditionAncestorTerm":"Adnexal Diseases" },{ "ConditionAncestorId":"D000005831", "ConditionAncestorTerm":"Genital Diseases, Female" },{ "ConditionAncestorId":"D000006058", "ConditionAncestorTerm":"Gonadal Disorders" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafAsFound":"Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12553", "ConditionBrowseLeafName":"Polycystic Ovary Syndrome", "ConditionBrowseLeafAsFound":"Polycystic Ovary Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3696", "ConditionBrowseLeafName":"Body Weight", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11554", "ConditionBrowseLeafName":"Ovarian Cysts", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5348", "ConditionBrowseLeafName":"Cysts", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11555", "ConditionBrowseLeafName":"Ovarian Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2224", "ConditionBrowseLeafName":"Adnexal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7526", "ConditionBrowseLeafName":"Genital Diseases, Female", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7746", "ConditionBrowseLeafName":"Gonadal Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" } ] } } } } } }