Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT00205504
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oral Contraceptives in the Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kicheang@vcu.edu', 'phone': '804-828-9698', 'title': 'Kai Cheang, Principal Investigator', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m².\n\nNote: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index)BMI \\<25 kg/m²', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tiredness', 'notes': "Subject felt tired during her last day of study and did not desire to continue that morning's study procedure.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain with venipuncture', 'notes': 'Subject withdrew withdrew after the first two mornings of study because of pain associated with venipuncture.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Phlebitis due to catheter insertion', 'notes': 'Subject experienced phlebitis at the site of catheter insertion. Subject was discontinued from the study by investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness due to Ortho Tricyclen', 'notes': 'Subject withdrew after 1 day of study medication (Ortho Tricyclen)due to dizziness.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gallstones removal', 'notes': 'Subject had gallstones removed during study, and continued study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline Insulin sensitivity', 'categories': [{'measurements': [{'value': '4.36', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '6.62', 'spread': '3.69', 'groupId': 'OG001'}]}]}, {'title': '6 months Insulin sensitivity', 'categories': [{'measurements': [{'value': '3.82', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '8.23', 'spread': '3.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline LDL', 'categories': [{'measurements': [{'value': '95', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '84', 'spread': '24.3', 'groupId': 'OG001'}]}]}, {'title': '6 months LDL', 'categories': [{'measurements': [{'value': '113', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '104', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Triglycerides', 'categories': [{'measurements': [{'value': '72', 'spread': '50.3', 'groupId': 'OG000'}, {'value': '72', 'spread': '52.0', 'groupId': 'OG001'}]}]}, {'title': '6 months Triglycerides', 'categories': [{'measurements': [{'value': '83', 'spread': '51.1', 'groupId': 'OG000'}, {'value': '106', 'spread': '52.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline HDL', 'categories': [{'measurements': [{'value': '51', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '53', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': '6 months HDL', 'categories': [{'measurements': [{'value': '58', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '61', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline Hs-CRP', 'categories': [{'measurements': [{'value': '4908.76', 'spread': '5215.07', 'groupId': 'OG000'}, {'value': '2050.77', 'spread': '4748.75', 'groupId': 'OG001'}]}]}, {'title': '6 months Hs-CRP', 'categories': [{'measurements': [{'value': '6207.76', 'spread': '4566.8', 'groupId': 'OG000'}, {'value': '2266.02', 'spread': '3443.3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Adiponectin', 'categories': [{'measurements': [{'value': '17568.86', 'spread': '5680.86', 'groupId': 'OG000'}, {'value': '21976.53', 'spread': '8322.05', 'groupId': 'OG001'}]}]}, {'title': '6 months Adiponectin', 'categories': [{'measurements': [{'value': '18408.43', 'spread': '4934.39', 'groupId': 'OG000'}, {'value': '22221.36', 'spread': '11160.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m².\n\nNote: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index)BMI \\<25 kg/m²'}], 'classes': [{'title': 'Baseline 16aE1', 'categories': [{'measurements': [{'value': '314.76', 'spread': '179.73', 'groupId': 'OG000'}, {'value': '317.47', 'spread': '159.8', 'groupId': 'OG001'}]}]}, {'title': '6 months 16aE1', 'categories': [{'measurements': [{'value': '421.6', 'spread': '286.57', 'groupId': 'OG000'}, {'value': '383.39', 'spread': '452.98', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 2ME1', 'categories': [{'measurements': [{'value': '25.92', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '32.39', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': '6 months 2ME1', 'categories': [{'measurements': [{'value': '52.84', 'spread': '54.29', 'groupId': 'OG000'}, {'value': '45.58', 'spread': '23.83', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 4ME1', 'categories': [{'measurements': [{'value': '5.26', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '3.13', 'groupId': 'OG001'}]}]}, {'title': '6 months 4ME1', 'categories': [{'measurements': [{'value': '6.1', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '8.55', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 2ME2', 'categories': [{'measurements': [{'value': '1.48', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': '6 months 2ME2', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline E1', 'categories': [{'measurements': [{'value': '217.23', 'spread': '170.88', 'groupId': 'OG000'}, {'value': '245.99', 'spread': '128.41', 'groupId': 'OG001'}]}]}, {'title': '6 months E1', 'categories': [{'measurements': [{'value': '315.03', 'spread': '339.15', 'groupId': 'OG000'}, {'value': '227.4', 'spread': '271.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 4ME2', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': '6 months 4ME2', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Baseline E2', 'categories': [{'measurements': [{'value': '34.11', 'spread': '15.61', 'groupId': 'OG000'}, {'value': '36.796', 'spread': '17.28', 'groupId': 'OG001'}]}]}, {'title': '6 months E2', 'categories': [{'measurements': [{'value': '74.73', 'spread': '117.52', 'groupId': 'OG000'}, {'value': '47.32', 'spread': '61.82', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 2OHE1', 'categories': [{'measurements': [{'value': '101.07', 'spread': '126.04', 'groupId': 'OG000'}, {'value': '85.62', 'spread': '48.08', 'groupId': 'OG001'}]}]}, {'title': '6 months 2OHE1', 'categories': [{'measurements': [{'value': '135.95', 'spread': '220.24', 'groupId': 'OG000'}, {'value': '57.96', 'spread': '70.02', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 2OHE2', 'categories': [{'measurements': [{'value': '9.81', 'spread': '5.85', 'groupId': 'OG000'}, {'value': '8.01', 'spread': '3.62', 'groupId': 'OG001'}]}]}, {'title': '6 months 2OHE2', 'categories': [{'measurements': [{'value': '11.55', 'spread': '21.74', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '4.69', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 4OHE1', 'categories': [{'measurements': [{'value': '33.78', 'spread': '16.52', 'groupId': 'OG000'}, {'value': '33.98', 'spread': '25.86', 'groupId': 'OG001'}]}]}, {'title': '6 months 4OHE1', 'categories': [{'measurements': [{'value': '27.29', 'spread': '25.65', 'groupId': 'OG000'}, {'value': '29.12', 'spread': '15.08', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Total plasma', 'categories': [{'measurements': [{'value': '1068', 'spread': '472.78', 'groupId': 'OG000'}, {'value': '1022.16', 'spread': '295.61', 'groupId': 'OG001'}]}]}, {'title': '6 months Total plasma', 'categories': [{'measurements': [{'value': '1342.21', 'spread': '1166.36', 'groupId': 'OG000'}, {'value': '1007.89', 'spread': '977.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline Waist-Hip Ratio', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.027', 'groupId': 'OG001'}]}]}, {'title': '6 months Waist-Hip Ratio', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.057', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with BMI \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with BMI \\>25 kg/m²'}], 'classes': [{'title': 'Baseline MCP-1', 'categories': [{'measurements': [{'value': '209.56', 'spread': '125.92', 'groupId': 'OG000'}, {'value': '156.14', 'spread': '36.29', 'groupId': 'OG001'}]}]}, {'title': '6 months MCP-1', 'categories': [{'measurements': [{'value': '219.86', 'spread': '159.85', 'groupId': 'OG000'}, {'value': '206.66', 'spread': '76.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m².\n\nNote: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index)BMI \\<25 kg/m²'}], 'classes': [{'title': 'Baseline Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '121.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '105.7', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': '6 months Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '123.5', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '106.5', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '74.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '68.0', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': '6 months Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '73.4', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '66.5', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline BMI', 'categories': [{'measurements': [{'value': '37.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '6 months BMI', 'categories': [{'measurements': [{'value': '37.6', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Body Mass Index is a calculation of height and weight: kg/m²', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline Waist circumference', 'categories': [{'measurements': [{'value': '100.0', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '6 months Waist circumference', 'categories': [{'measurements': [{'value': '101.0', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '70.9', 'spread': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m²'}, {'id': 'OG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index (BMI) \\<25 kg/m²'}], 'classes': [{'title': 'Baseline sVCAM', 'categories': [{'measurements': [{'value': '905', 'spread': '190.63', 'groupId': 'OG000'}, {'value': '1139.6', 'spread': '159.57', 'groupId': 'OG001'}]}]}, {'title': '6 months sVCAM', 'categories': [{'measurements': [{'value': '880.14', 'spread': '180.08', 'groupId': 'OG000'}, {'value': '1003.29', 'spread': '256.62', 'groupId': 'OG001'}]}]}, {'title': 'Baseline sICAM', 'categories': [{'measurements': [{'value': '163.34', 'spread': '50.44', 'groupId': 'OG000'}, {'value': '182.11', 'spread': '91.17', 'groupId': 'OG001'}]}]}, {'title': '6 months sICAM', 'categories': [{'measurements': [{'value': '163.2', 'spread': '27.71', 'groupId': 'OG000'}, {'value': '160.21', 'spread': '74.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m².\n\nNote: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.'}, {'id': 'FG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index)BMI \\<25 kg/m²'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Although 46 completed informed consent, only 36 initiated the study. Among The participants who did not begin the study were lost to follow-up prior to beginning the protocol, were no shows, or withdrew from the study before beginning study procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Obese Women', 'description': 'Women with Body Mass Index (BMI) \\>30 kg/m².\n\nNote: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.'}, {'id': 'BG001', 'title': 'Lean Women', 'description': 'Women with Body Mass Index)BMI \\<25 kg/m²'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '21.4', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '23.4', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-10', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).'}], 'secondaryOutcomes': [{'measure': 'Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).'}, {'measure': 'Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.'}, {'measure': 'Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.'}, {'measure': 'Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).'}, {'measure': 'Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'Body Mass Index is a calculation of height and weight: kg/m²'}, {'measure': 'Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women', 'timeFrame': 'Baseline and 6 months', 'description': 'These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).'}]}, 'conditionsModule': {'keywords': ['Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X'], 'conditions': ['Metabolic Syndrome X', 'Insulin Resistance', 'Obesity', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '21676394', 'type': 'RESULT', 'citation': 'Cheang KI, Essah PA, Sharma S, Wickham EP 3rd, Nestler JE. Divergent effects of a combined hormonal oral contraceptive on insulin sensitivity in lean versus obese women. Fertil Steril. 2011 Aug;96(2):353-359.e1. doi: 10.1016/j.fertnstert.2011.05.039. Epub 2011 Jun 15.'}]}, 'descriptionModule': {'briefSummary': "Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol \\< 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular events in OC users with emerging cardiovascular risk factors (such as obesity and the metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors in a single individual, and its underlying cause may be insulin resistance. Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied. This is a critical problem because the metabolic syndrome is prevalent in 24% of adults. Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC with the least harm would not be possible.\n\nThe investigator's long-term goal is to understand the best way to prevent and treat cardiovascular disease in women. The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and cardiovascular risks in women taking OCs. The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use, when compared to normal weight women without the metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular events in women taking OCs, and will serve as pilot data for a National Institutes of Health (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians can make better informed decisions about contraceptive choices for their patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acceptable health based on interview, medical history, physical examination, and laboratory tests (comprehensive metabolic panel - SMA20, and complete blood count - CBC);\n2. Have not taken oral contraceptives (OCs) in the past 3 months;\n3. Ability to comply with the requirements of the study;\n4. Ability and willingness to provide signed, witnessed informed consent. In addition, women with the metabolic syndrome must meet the National Cholesterol Education Program (NCEP) defined criteria of the metabolic syndrome, that is, having at least 3 of the 5 factors:\n\n 1. increased waist circumference \\> 35 inches,\n 2. hypertriglyceridemia ≥ 150 mg/dL,\n 3. low high-density lipoprotein (HDL) cholesterol \\< 50 mg/dL in women,\n 4. hypertension (≥ 130/≥ 85 mmHg),\n 5. fasting glucose ≥ 100 mg/dL.\n\nObese women with or without the metabolic syndrome should have a Body Mass Index (BMI) \\> 30 kg/m2 and lean women should have a Body Mass Index BMI \\< 25 kg/m2.\n\nExclusion Criteria:\n\n1. Diabetes mellitus by fasting glucose or a 2-hour oral glucose tolerance test (OGTT);\n2. Clinically significant pulmonary, cardiac (including but not limited to ischemic heart disease, stable/unstable angina, and congestive heart failure), renal, hepatic, cholestatic, neurologic, psychiatric, infectious, and malignant disease (other than melanoma skin cancer);\n3. History of thromboembolism, myocardial infarction, cerebrovascular accident, vascular disease, known coagulopathy, prolonged immobilization, or recent major surgery (within past 6 months);\n4. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg (mild hypertension is not an exclusion criterion);\n5. History of breast cancer, migraine headaches, or age ≥ 35 years and smoker of ≥ 20 cigarettes/day;\n6. Use of metformin, thiazolidinediones, anti-hyperlipidemic drugs, anti-hypertensive drugs, glucocorticoids, or anti-androgens (spironolactone, flutamide, etc.) within 3 months;\n7. Documented or suspected illicit drug abuse or alcoholism within one year;\n8. Ingestion of any investigational drugs within 3 months prior to the study onset; and\n9. Pregnancy or lactation (≤ 6 weeks postpartum);\n10. Hematocrit \\< 33g/dL. These exclusion criteria are based on study requirements and also go beyond guidelines for OC use published by the World Health Organization.'}, 'identificationModule': {'nctId': 'NCT00205504', 'briefTitle': 'Oral Contraceptives in the Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Oral Contraceptives in the Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'HM4060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Obese women with metabolic syndrome', 'interventionNames': ['Drug: Ortho Tri Cyclen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese women without metabolic syndrome', 'interventionNames': ['Drug: Ortho Tri Cyclen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lean women without metabolic syndrome', 'interventionNames': ['Drug: Ortho Tri Cyclen']}], 'interventions': [{'name': 'Ortho Tri Cyclen', 'type': 'DRUG', 'description': 'Ortho Tri Cyclen, one tablet daily, for 6 cycles', 'armGroupLabels': ['Obese women with metabolic syndrome', 'Obese women without metabolic syndrome', 'lean women without metabolic syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University General Clinical Research Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Kai I Cheang, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}, {'name': 'John E Nestler, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}