Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00827632
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2009-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Obesity, Oral Contraception, and Ovarian Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clw3@columbia.edu', 'phone': '212-305-4805', 'title': 'Carolyn Westhoff', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Normal Weight', 'description': 'Participants with a Body Mass Index (BMI) of 19-24.9.', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese', 'description': 'Participants with a Body Mass Index (BMI) of 30-39.9.', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Weight', 'description': 'Participants with a Body Mass Index (BMI) of 19-24.9.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants with a Body Mass Index (BMI) of 30-39.9.'}], 'classes': [{'title': 'Score of 1 - no activity', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Score of 2 - potential activity', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Score of 3 - nonactive follicle-like structure', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Score of 4 - active follicle-like structure', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Score of 5/6 - luteinization or ovulation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 biweekly visits from start of OCP therapy', 'description': 'Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined):\n\n1. no activity\n2. potential activity\n3. nonactive follicle-like structure\n4. active follicle-like structure\n5. luteinized unruptured follicle\n6. ovulation\n\nEach participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese).'}, {'type': 'SECONDARY', 'title': 'Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Weight', 'description': 'Participants with a Body Mass Index (BMI) of 19-24.9.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants with a Body Mass Index (BMI) of 30-39.9.'}], 'classes': [{'title': 'Baseline Carbohydrate - Glucose', 'categories': [{'measurements': [{'value': '87.2', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '90.2', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Exit Carbohydrate - Glucose', 'categories': [{'measurements': [{'value': '89.8', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '92.7', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Lipid - Total Cholesterol', 'categories': [{'measurements': [{'value': '171.4', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '177.0', 'spread': '27.2', 'groupId': 'OG001'}]}]}, {'title': 'Exit Lipid - Total Cholesterol', 'categories': [{'measurements': [{'value': '172.3', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '170.4', 'spread': '35.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (baseline) and follow-up 1 (exit)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We excluded participants who were not compliant with the study treatment (based on measuring serum hormone concentrations) from the analyses.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Weight', 'description': 'Participants with a Body Mass Index (BMI) of 19-24.9.'}, {'id': 'OG001', 'title': 'Obese', 'description': 'Participants with a Body Mass Index (BMI) of 30-39.9.'}], 'timeFrame': '24 hours during week 3 of follow-up cycle', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not available. No analysis performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Weight', 'description': 'Participants with a Body Mass Index (BMI) of 19-24.9.'}, {'id': 'FG001', 'title': 'Obese', 'description': 'Participants with a Body Mass Index (BMI) of 30-39.9.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Early withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Participant-related activities were conducted between July 2006-December 2008 in New York City', 'preAssignmentDetails': 'Eligible women were aged 18-35 years with a recent history of regular, spontaneous menstrual cycles, and agreed to use an Oral Contraceptive Pill (OCP) for 3 to 4 months and undergo eight biweekly study visits during the third or fourth OCP cycle.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Weight', 'description': 'Participants with a Body Mass Index (BMI) of 19-24.9.'}, {'id': 'BG001', 'title': 'Obese', 'description': 'Participants with a Body Mass Index (BMI) of 30-39.9.'}, {'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': '106', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '181', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic African American', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Non-compliant OCP users (dropped from analysis)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Oral Contraceptive Pill Compliance', 'classes': [{'title': 'Consistent Users', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': 'Inconsistent Users', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Nonusers', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2009-01-21', 'resultsFirstSubmitDate': '2010-10-11', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-16', 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.', 'timeFrame': 'Up to 8 biweekly visits from start of OCP therapy', 'description': 'Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined):\n\n1. no activity\n2. potential activity\n3. nonactive follicle-like structure\n4. active follicle-like structure\n5. luteinized unruptured follicle\n6. ovulation\n\nEach participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score.'}], 'secondaryOutcomes': [{'measure': 'Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).', 'timeFrame': 'Screening (baseline) and follow-up 1 (exit)'}, {'measure': 'Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.', 'timeFrame': '24 hours during week 3 of follow-up cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian Suppression', 'Oral Contraceptives', 'Obese and Normal BMI'], 'conditions': ['Ovarian Suppression']}, 'referencesModule': {'references': [{'pmid': '24156617', 'type': 'DERIVED', 'citation': 'Mayeda ER, Torgal AH, Westhoff CL. Weight and body composition changes during oral contraceptive use in obese and normal weight women. J Womens Health (Larchmt). 2014 Jan;23(1):38-43. doi: 10.1089/jwh.2012.4241. Epub 2013 Oct 24.'}, {'pmid': '20664386', 'type': 'DERIVED', 'citation': 'Westhoff CL, Torgal AH, Mayeda ER, Stanczyk FZ, Lerner JP, Benn EKT, Paik M. Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):275-283. doi: 10.1097/AOG.0b013e3181e79440.'}]}, 'descriptionModule': {'briefSummary': 'This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.', 'detailedDescription': 'There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-35\n* Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m\\^2\n* Willing to take birth control pills for 3-4 months\n* Recent spontaneous pregnancy or cyclic menses\n\nExclusion Criteria:\n\n* Contraindications to hormonal contraceptives\n* Oophorectomy/Polycystic ovary syndrome (PCOS)\n* Taken oral contraceptives to regulate menses recently\n* Weight reduction surgery\n* Used Depo-Provera within the last 12 months\n* Pregnant or currently breastfeeding\n* Desiring pregnancy within the next 4 months\n* Unable to make study visit commitment\n* Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT00827632', 'acronym': '20/30', 'briefTitle': 'Obesity, Oral Contraception, and Ovarian Suppression', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Oral Contraception and Ovarian Suppression in Women With Different Weights', 'orgStudyIdInfo': {'id': 'AAAB4823'}, 'secondaryIdInfos': [{'id': 'R01HD045786', 'link': 'https://reporter.nih.gov/quickSearch/R01HD045786', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Weight group', 'description': 'Participants with a BMI of 19-24.9 kg/m\\^2', 'interventionNames': ['Drug: Low dose formulation', 'Drug: High dose formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese group', 'description': 'Participants with a BMI of 30-39.9 kg/m\\^2', 'interventionNames': ['Drug: Low dose formulation', 'Drug: High dose formulation']}], 'interventions': [{'name': 'Low dose formulation', 'type': 'DRUG', 'otherNames': ['Low dose'], 'description': 'Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.\n\nDose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.', 'armGroupLabels': ['Normal Weight group', 'Obese group']}, {'name': 'High dose formulation', 'type': 'DRUG', 'otherNames': ['High dose'], 'description': 'Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.\n\nDose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.', 'armGroupLabels': ['Normal Weight group', 'Obese group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Carolyn Westhoff, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center', 'investigatorFullName': 'Carolyn L. Westhoff', 'investigatorAffiliation': 'Columbia University'}}}}