Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-29 @ 4:19 AM
Study NCT ID:
NCT00714233
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2008-07-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'C534342', 'term': 'drospirenone and ethinyl estradiol combination'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kathy_hoeger@urmc.rochester.edu', 'phone': '5852757891', 'title': 'Kathleen M Hoeger MD MPH', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks'}, {'id': 'OG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance'}, {'id': 'OG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly'}, {'id': 'OG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 week', 'description': 'The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was a description of number of recruited subjects.'}, {'type': 'SECONDARY', 'title': 'Weight Loss in Lifestyle Intervention Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Program', 'description': 'Subjects enrolled in a nutrition and exercise program'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '6.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Paired t-test to analyze BMI at baseline and 24 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Free Androgen Index (FAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Group assigned to metformin with free androgen index measured'}, {'id': 'OG001', 'title': 'Oral Contraceptive', 'description': 'group assigned to oral contraceptive for 24 weeks'}, {'id': 'OG002', 'title': 'Lifestle', 'description': 'Those assigned to a nutrition and exercise program'}, {'id': 'OG003', 'title': 'Placebo to Metformin', 'description': 'Matched to metformin pill'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '8', 'groupId': 'OG001'}, {'value': '-13.7', 'spread': '10.9', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '12.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI \\<4 is consistent with a normal range.', 'unitOfMeasure': 'total T/SHBG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis per protocol'}, {'type': 'SECONDARY', 'title': 'Change in SHBG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks'}, {'id': 'OG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance'}, {'id': 'OG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly'}, {'id': 'OG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '77', 'spread': '38.4', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '18.3', 'groupId': 'OG002'}, {'value': '2', 'spread': '8.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Measurement of SHBG by treatment group pre and post intervention', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglyceride Concentration by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks'}, {'id': 'OG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance'}, {'id': 'OG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly'}, {'id': 'OG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.3', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '41', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '36.4', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '27.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks'}, {'id': 'OG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance'}, {'id': 'OG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly'}, {'id': 'OG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '-1.1', 'spread': '7.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change in fasting glucose concentration by treatment group pre to post intervention', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks'}, {'id': 'FG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance'}, {'id': 'FG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly'}, {'id': 'FG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin', 'description': 'Randomized to Metformin 1700mg daily for 24 weeks'}, {'id': 'BG001', 'title': 'Oral Contraceptive', 'description': 'Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance'}, {'id': 'BG002', 'title': 'Lifestyle Counseling', 'description': 'lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly'}, {'id': 'BG003', 'title': 'Placebo to Metformin', 'description': 'randomized to placebo pill identical to active metformin arm'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '15.4', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '15.4', 'spread': '1.7', 'groupId': 'BG003'}, {'value': '15.6', 'spread': '1.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2008-07-08', 'resultsFirstSubmitDate': '2011-04-08', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-12', 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification', 'timeFrame': '24 week', 'description': 'The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY'}], 'secondaryOutcomes': [{'measure': 'Weight Loss in Lifestyle Intervention Group', 'timeFrame': 'baseline and 24 weeks', 'description': 'In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI'}, {'measure': 'Change in Free Androgen Index (FAI)', 'timeFrame': 'baseline and 24 weeks', 'description': 'Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI \\<4 is consistent with a normal range.'}, {'measure': 'Change in SHBG', 'timeFrame': 'baseline and 24 weeks', 'description': 'Measurement of SHBG by treatment group pre and post intervention'}, {'measure': 'Triglyceride Concentration by Treatment Group', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo'}, {'measure': 'Change in Fasting Glucose', 'timeFrame': 'baseline and 24 weeks', 'description': 'Change in fasting glucose concentration by treatment group pre to post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'Overweight Adolescent Girls', 'Irregular Menstrual Cycles'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:\n\n1. reduce fasting glucose levels\n2. reduce androgen hormone levels\n3. improve sex steroid binding, and\n4. improve lipids (fatty substances in the blood)', 'detailedDescription': "Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.\n\nMany adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Menstrual irregularity defined as cycle length \\> 45 days\n* Overweight as BMI \\> 25\n* Clinical evidence of hirsuitism or acne\n* Testosterone \\> 50ng/dL\n\nExclusion Criteria:\n\n* History of diabetes mellitus\n* History of Cushing's disease\n* History of hyperprolactinemia\n* Untreated hypo or hyperthyroidism\n* History of adrenal hyperplasia\n* Significant renal impairment\n* Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study\n* Exercise \\> 10 hours per week"}, 'identificationModule': {'nctId': 'NCT00714233', 'briefTitle': 'Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents', 'orgStudyIdInfo': {'id': 'RSRB # 09354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Oral Contraceptive Pills', 'interventionNames': ['Drug: Oral Contraceptive Pills (Yasmin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'lifestyle modification program', 'interventionNames': ['Behavioral: Lifestyle Modification']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'placebo to active metformin arm', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 425mg. capsules, 2 capsules BID x 24 weeks', 'armGroupLabels': ['1']}, {'name': 'Oral Contraceptive Pills (Yasmin)', 'type': 'DRUG', 'otherNames': ['Yasmin oral COntraceptive tabs'], 'description': 'Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks', 'armGroupLabels': ['2']}, {'name': 'Lifestyle Modification', 'type': 'BEHAVIORAL', 'description': 'weekly classes x 24 weeks for training in diet, exercise and behavior modification skills', 'armGroupLabels': ['3']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['pharmacy matched placebo capsules'], 'description': 'placebo to the active metformin arm. 2 capsules BID x 24 weeks.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kathleen M Hoeger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kathleen M. Hoeger, MD', 'investigatorAffiliation': 'University of Rochester'}}}}