Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-30 @ 9:45 AM
Study NCT ID:
NCT03981861
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2019-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013148', 'term': 'Spironolactone'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsburgert@cmh.edu', 'phone': '203 676 4545', 'title': 'Tania Burgert', 'organization': 'ChildrensMHC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data. Study was not published for this reason.'}}, 'adverseEventsModule': {'timeFrame': "adverse event data was collected for the duration of the subject's intervention: 6 months", 'description': 'Metformin is not known to cause death or hospitalization.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Study', 'description': 'The pilot study was a non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oral Glucose Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Measurement of glucose and insulin at baseline and 2 hours after 75g of glucola.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.57', 'spread': '11.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Total Testosterone measured in ng/dL', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Free Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Free Testosterone measured in ng/dL', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dehydroepiandrosterone Sulfate (DHEAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.89', 'spread': '79.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'DHEAS measured in mcg/dL', 'unitOfMeasure': 'mcg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study', 'description': 'This was a pilot non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Body Mass Index measured in kg/m2', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'The pilot study was a non-controlled open label drug intervention study in a sample of adolescent girls attending a polycystic ovary syndrome (PCOS) clinic. Subjects received 6 months combination drug therapy with a combination of low dose metformin and spironolactone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Treatment with Metformin and Spironolactone\n\nMetformin and Spironolactone: Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'female', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'whole body insulin sensitivity index (WBISI)', 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '4.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'WBISI does not have a lot of normative data to help categorize values. However, \\< 4.3 is deemed insulin resistant. The lower the number the more insulin resistant.', 'unitOfMeasure': 'μU/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-17', 'size': 513342, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-08T15:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2019-06-07', 'resultsFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-04', 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Glucose Tolerance Test', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Measurement of glucose and insulin at baseline and 2 hours after 75g of glucola.'}, {'measure': 'Total Testosterone', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Total Testosterone measured in ng/dL'}, {'measure': 'Free Testosterone', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Free Testosterone measured in ng/dL'}, {'measure': 'Dehydroepiandrosterone Sulfate (DHEAS)', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'DHEAS measured in mcg/dL'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Change Measures: Baseline & 6 Months', 'description': 'Body Mass Index measured in kg/m2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PCOS']}, 'descriptionModule': {'briefSummary': 'To exam in the effect of a combination of low dose Metformin and Spironolactone on functional brain MRI, menstrual regulation and metabolism in adolescents with PCOS.', 'detailedDescription': 'Polycystic Ovarian Syndrome (PCOS) is the most common endocrinopathy in adolescent females and also one of the most complex. Patients experience an exaggerated ovarian/adrenal androgen production in response to physiologic and supra-physiologic elevations in insulin. The hormonal dysregulation is not only associated with acne, hirsutism, and menstrual irregularity, but also with perpetuated insulin resistance, central adiposity, and clinical depression.\n\nIn the proposed study, we aim to treat a hormonally and metabolically well-defined group of adolescent girls with PCOS with a combination of two pharmacological agents: metformin (insulin sensitizer) and spironolactone (anti-androgen) for 6 months. Although hyperandrogenism is a fundamental component of PCOS and responsible for the perpetuation of insulin resistance, adiposity and anovulation, there are few pediatric studies that have examined the benefits of treating both insulin resistance and hyperandrogenism simultaneously. Preliminary studies in adults, however, suggest synergistic effect of both spironolactone and metformin (spiro-met) with near normalization of the metabolic and ovulatory dysfunction. Therefore, we hypothesize that spiro-met will improve adolescent metabolism, body composition, ovarian morphology/function. We anticipate that our study will generate key pilot data for further randomized, double blind placebo controlled trials using both agents.\n\nWe also plan to examine functional brain MRI before and after the spiro-met intervention. This will allow us to inspect the effects of the hyperinsulinemic/androgenic hormonal milieu in PCOS on structural and functional brain MRI. We hypothesis, that the hormonal environment in PCOS affects centers of appetite and mood.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* Meeting Androgen Excess Society (AES) diagnostic criteria of PCOS: Menstrual Dysfunction or PCO ovaries on ultrasound AND clinical or biochemical hyperandrogenism\n* Normal liver and kidney function\n* No chronic illnesses except for stable, treated hypothyroidism\n\nExclusion Criteria:\n\n* Use of metformin and/or spironolactone within the last 6 months\n* Currently on either oral hormonal contraception or other forms of hormonal contraception such as Depo-Provera, NuvaRing\n* Current or past pregnancy\n* Currently sexually active\n* Psychiatric disorder based on self/parental report\n* Type 2 diabetes (blood glucose \\> 200mg/dl on OGTT)\n* Anemia (Hct \\< 35)\n* Impaired kidney function (Baseline creatinine \\> 1.0 mg)\n* Abnormal liver transaminases \\> 2 x the upper limit of normal range\n* Potassium elevated outside the reference range (in non-hemolyzed blood sample)'}, 'identificationModule': {'nctId': 'NCT03981861', 'briefTitle': 'Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Metabolic and Neuro-Endocrine Effect of Treating PCOS in Adolescents', 'orgStudyIdInfo': {'id': '16010020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Overall Study', 'description': 'Treatment with Metformin and Spironolactone', 'interventionNames': ['Drug: Metformin and Spironolactone']}], 'interventions': [{'name': 'Metformin and Spironolactone', 'type': 'DRUG', 'description': 'Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months.', 'armGroupLabels': ['Overall Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Tania Burgert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}