{ "FullStudy":{ "Rank":218170, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511822", "OrgStudyIdInfo":{ "OrgStudyId":"Dros_Myo2012" }, "Organization":{ "OrgFullName":"AGUNCO Obstetrics and Gynecology Centre", "OrgClass":"OTHER" }, "BriefTitle":"Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 18, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"AGUNCO Obstetrics and Gynecology Centre", "LeadSponsorClass":"OTHER" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome with a variety of metabolic and endocrine abnormalities and clinical symptoms.\n\nThe primary defect in PCOS consists of an abnormal androgen synthesis and secretion, particularly by ovarian theca cells. Insulin resistance and obesity may act as triggers, explaining the frequent association of PCOS with these metabolic conditions. Hyperinsulinaemia, which results from insulin resistance, stimulates both ovarian and adrenal androgen secretion and suppresses sex hormone-binding globulin synthesis from the liver. It results in an increase in free, biologically active androgens which are related to clinical signs such as hirsutism, acne, seborrhea, and alopecia.\n\nCombined oral contraceptive (COC) therapy is a common treatment for PCOS and it was widely used in this group of patients providing clinical improvement in the areas of excessive hair growth, unpredictable menses, acne, and weight gain.\n\nMore recent studies outlined a deficiency in myo-inositol in women with PCOS and insulin-resistance. Myo-inositol is a precursor for many inositol-containing compounds and it plays critical and diverse roles in signal transduction, membrane biogenesis, vesicle trafficking, and chromatin remodeling. It is a precursor in the synthesis of phosphatidylinositol polyphosphates (PIPs) that are a source of several second messengers.\n\nIt has been reported that the administration of myo-inositol reduces serum insulin, decreases serum testosterone and enhances ovulation.\n\nDue to the different beneficial actions, the aim of the present study is to evaluate the clinical, metabolic and endocrine effects of treatment with COC (drospirenone and ethinyl estradiol)alone or in combination with myo-inositol, in young women with PCOS and insulin resistance." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "PCOS", "Polycystic Ovary Syndrome" ] }, "KeywordList":{ "Keyword":[ "PCOS", "Insulin resistance", "Hyperandrogenism", "Myo-inositol" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Drospirenone + Ethinyl estradiol", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Drospirenone Ethinyl estradiol" ] } },{ "ArmGroupLabel":"Drospirenone + Ethinyl estradiol + Myo-inositol", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Drospirenone Ethinyl estradiol Myo-inositol" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Drospirenone Ethinyl estradiol", "InterventionDescription":"Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Drospirenone + Ethinyl estradiol" ] } },{ "InterventionType":"Drug", "InterventionName":"Drospirenone Ethinyl estradiol Myo-inositol", "InterventionDescription":"Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Drospirenone + Ethinyl estradiol + Myo-inositol" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Score acne (acne grading system by Cook et al)" },{ "PrimaryOutcomeMeasure":"Score hirsutism (Ferriman-Gallwey classification)" },{ "PrimaryOutcomeMeasure":"Measurement of sex hormones in serum" },{ "PrimaryOutcomeMeasure":"Oral glucose tolerance test (OGTT)" },{ "PrimaryOutcomeMeasure":"Measurement of blood glucose and insulin levels" },{ "PrimaryOutcomeMeasure":"BMI" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of patients with adverse effects" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWomen fulfilled two out of three diagnostic criteria for PCOS, according to the 2003 Rotterdam Consensus conference\nWomen with PCOS, insulin resistance, acne, hirsutism and seborrhea\n\nExclusion Criteria:\n\nWomen with pre-existing secondary endocrine disorders\nWomen wishing to conceive during the next 12 months\nWomen with contradictions to oral contraceptive use\nWomen with personal history of hypertension, diabetes mellitus or cardiovascular disorders\nWomen who received treatment with oral contraceptives, or other drugs for the previous 6 months before entering the study.", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"35 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Istituto di Patologia Ostetrica e Ginecologica", "LocationCity":"Catania", "LocationCountry":"Italy" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"22122627", "ReferenceType":"background", "ReferenceCitation":"D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28." },{ "ReferencePMID":"21417594", "ReferenceType":"background", "ReferenceCitation":"Minozzi M, Costantino D, Guaraldi C, Unfer V. The effect of a combination therapy with myo-inositol and a combined oral contraceptive pill versus a combined oral contraceptive pill alone on metabolic, endocrine, and clinical parameters in polycystic ovary syndrome. Gynecol Endocrinol. 2011 Nov;27(11):920-4. doi: 10.3109/09513590.2011.564685. Epub 2011 Mar 21." },{ "ReferencePMID":"18728832", "ReferenceType":"background", "ReferenceCitation":"Mathur R, Levin O, Azziz R. Use of ethinylestradiol/drospirenone combination in patients with the polycystic ovary syndrome. Ther Clin Risk Manag. 2008 Apr;4(2):487-92." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007294", "InterventionMeshTerm":"Inositol" },{ "InterventionMeshId":"C000035144", "InterventionMeshTerm":"Drospirenone" },{ "InterventionMeshId":"C000074283", "InterventionMeshTerm":"Estradiol 3-benzoate" },{ "InterventionMeshId":"C000007630", "InterventionMeshTerm":"Estradiol 17 beta-cypionate" },{ "InterventionMeshId":"C000534342", "InterventionMeshTerm":"Drospirenone and ethinyl estradiol combination" },{ "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":"D000014803", "InterventionAncestorTerm":"Vitamin B Complex" },{ "InterventionAncestorId":"D000014815", "InterventionAncestorTerm":"Vitamins" },{ "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "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":"M8919", "InterventionBrowseLeafName":"Inositol", "InterventionBrowseLeafAsFound":"Inositol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M215415", "InterventionBrowseLeafName":"Drospirenone", "InterventionBrowseLeafAsFound":"Drospirenone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M190963", "InterventionBrowseLeafName":"Drospirenone and ethinyl estradiol combination", "InterventionBrowseLeafAsFound":"Drospirenone Ethinyl estradiol", "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":"M16141", "InterventionBrowseLeafName":"Vitamins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7201", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16129", "InterventionBrowseLeafName":"Vitamin B Complex", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15468", "InterventionBrowseLeafName":"Trace Elements", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19593", "InterventionBrowseLeafName":"Micronutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1986", "InterventionBrowseLeafName":"Nutrients", "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" },{ "InterventionBrowseLeafId":"T400", "InterventionBrowseLeafName":"Inositol", "InterventionBrowseLeafAsFound":"Inositol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T446", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T448", "InterventionBrowseLeafName":"Folate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T475", "InterventionBrowseLeafName":"Vitamin B9", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"NaAg", "InterventionBrowseBranchName":"Natriuretic Agents" },{ "InterventionBrowseBranchAbbrev":"Hemat", "InterventionBrowseBranchName":"Hematinics" },{ "InterventionBrowseBranchAbbrev":"Ot", "InterventionBrowseBranchName":"Other Dietary Supplements" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011085", "ConditionMeshTerm":"Polycystic Ovary Syndrome" },{ "ConditionMeshId":"D000007333", "ConditionMeshTerm":"Insulin Resistance" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004194", "ConditionAncestorTerm":"Disease" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000006946", "ConditionAncestorTerm":"Hyperinsulinism" },{ "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "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":"M8953", "ConditionBrowseLeafName":"Insulin Resistance", "ConditionBrowseLeafAsFound":"Insulin Resistance", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12553", "ConditionBrowseLeafName":"Polycystic Ovary Syndrome", "ConditionBrowseLeafAsFound":"Polycystic Ovary Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18417", "ConditionBrowseLeafName":"Hyperandrogenism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8580", "ConditionBrowseLeafName":"Hyperinsulinism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "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":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "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" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" } ] } } } } } }