Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT00335257
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dinger@zeg-berlin.de', 'phone': '0049(0)30 945 10120', 'title': 'Juergen Dinger, MD, PhD', 'organization': 'Center for Epidemiology and Health Research, Germany'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'In non-experimental studies the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.'}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected over a time period of 5 years.', 'description': 'Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.', 'eventGroups': [{'id': 'EG000', 'title': 'DRSP-24d', 'description': '24-day regimen of DRSP/EE', 'otherNumAtRisk': 7264, 'otherNumAffected': 0, 'seriousNumAtRisk': 7264, 'seriousNumAffected': 583}, {'id': 'EG001', 'title': 'DRSP-21d', 'description': '21-day regimen of DRSP/EE', 'otherNumAtRisk': 5605, 'otherNumAffected': 0, 'seriousNumAtRisk': 5605, 'seriousNumAffected': 499}, {'id': 'EG002', 'title': 'OCs Non-DRSP', 'description': 'Users of OCs containing other progestins', 'otherNumAtRisk': 39316, 'otherNumAffected': 0, 'seriousNumAtRisk': 39316, 'seriousNumAffected': 2740}, {'id': 'EG003', 'title': 'NOHC', 'description': 'Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)', 'otherNumAtRisk': 4070, 'otherNumAffected': 0, 'seriousNumAtRisk': 4070, 'seriousNumAffected': 254}, {'id': 'EG004', 'title': 'No Use', 'description': 'No (hormonal) contraception)', 'otherNumAtRisk': 28854, 'otherNumAffected': 0, 'seriousNumAtRisk': 28854, 'seriousNumAffected': 1756}], 'seriousEvents': [{'term': 'Infectious diseases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 137}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 68}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Neoplasms, malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 119}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 57}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Neoplasms, benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Diseases of the blood and blood-forming organs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Endocrine diseases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 26}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Psychiatric and neurological disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 226}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 109}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Cardiovascular system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 278}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 98}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Respiratory system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 183}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 77}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Digestive system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 116}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 553}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 56}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 259}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Musculoskeletal system and connective tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Genitourinary system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 471}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 253}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Pregnancy, delivery and puerperium', 'notes': 'SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 151}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 571}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Injury, poisoning, accidents, etc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7264, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 5605, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 39316, 'numAffected': 383}, {'groupId': 'EG003', 'numAtRisk': 4070, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 28854, 'numAffected': 136}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7264', 'groupId': 'OG000'}, {'value': '5605', 'groupId': 'OG001'}, {'value': '39316', 'groupId': 'OG002'}, {'value': '4070', 'groupId': 'OG003'}, {'value': '28854', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'OC DRSP-24d', 'description': '24-day regimen of DRSP/EE'}, {'id': 'OG001', 'title': 'OC DRSP-21d', 'description': '21-day regimen of DRSP/EE'}, {'id': 'OG002', 'title': 'OCs Non-DRSP', 'description': 'Users of OCs containing other progestins than DRSP'}, {'id': 'OG003', 'title': 'NOHC', 'description': 'Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)'}, {'id': 'OG004', 'title': 'No Use', 'description': 'No (hormonal) contraception at last contact'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.3', 'estimateComment': 'Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE', 'groupDescription': 'Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 60 months', 'description': 'Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants that were not excluded due to protocol violation'}, {'type': 'PRIMARY', 'title': 'Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7264', 'groupId': 'OG000'}, {'value': '5605', 'groupId': 'OG001'}, {'value': '39316', 'groupId': 'OG002'}, {'value': '4070', 'groupId': 'OG003'}, {'value': '28854', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'OC DRSP-24d', 'description': '24-day regimen of DRSP/EE'}, {'id': 'OG001', 'title': 'OC DRSP-21d', 'description': '21-day regimen of DRSP/EE'}, {'id': 'OG002', 'title': 'OCs Non-DRSP', 'description': 'Users of OCs containing other progestins'}, {'id': 'OG003', 'title': 'NOHC', 'description': 'Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)'}, {'id': 'OG004', 'title': 'No Use', 'description': 'No (hormonal) contraception'}], 'classes': [{'title': 'Total number of ATE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'of which acute myocardial infarction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'of which ichemic stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'of which transient ischemic attack (TIA)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'of which peripheral ATE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 60 months', 'description': 'Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants that were not excluded due to protocol violation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OC DRSP-24d', 'description': 'OCs containing DRSP (Yaz®, 24 day regimen)'}, {'id': 'FG001', 'title': 'OC DRSP-21d', 'description': 'OCs containing DRSP (Yasmin®, 21 day regimen)'}, {'id': 'FG002', 'title': 'OCs Non-DRSP', 'description': 'Users of OCs containing other progestins'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15542'}, {'groupId': 'FG001', 'numSubjects': '9377'}, {'groupId': 'FG002', 'numSubjects': '60190'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Numbers completed refer to first follow-up. Individual follow-up ranged between 0.5 and 6.0 years.', 'groupId': 'FG000', 'numSubjects': '15542'}, {'groupId': 'FG001', 'numSubjects': '9377'}, {'comment': 'Numbers completed refer to first follow-up. Individual follow-up ranged between 0.5 and 6.0 years.', 'groupId': 'FG002', 'numSubjects': '60190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 91,474 patients were recruited for the INAS-OC study. Of these, 6,365 participants were excluded due to protocol violations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15542', 'groupId': 'BG000'}, {'value': '9377', 'groupId': 'BG001'}, {'value': '60190', 'groupId': 'BG002'}, {'value': '85109', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OC DRSP-24d', 'description': 'OCs containing DRSP (Yaz®, 24 day regimen )'}, {'id': 'BG001', 'title': 'OC DRSP-21d', 'description': 'OCs containing DRSP (Yasmin®, 21 day regimen)'}, {'id': 'BG002', 'title': 'OCs Non-DRSP', 'description': 'Users of OCs containing other progestins'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2054', 'groupId': 'BG000'}, {'value': '1149', 'groupId': 'BG001'}, {'value': '7582', 'groupId': 'BG002'}, {'value': '10785', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13488', 'groupId': 'BG000'}, {'value': '8227', 'groupId': 'BG001'}, {'value': '52608', 'groupId': 'BG002'}, {'value': '74323', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.21', 'spread': '7.64', 'groupId': 'BG000'}, {'value': '26.14', 'spread': '7.48', 'groupId': 'BG001'}, {'value': '26.34', 'spread': '7.73', 'groupId': 'BG002'}, {'value': '26.29', 'spread': '7.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15542', 'groupId': 'BG000'}, {'value': '9377', 'groupId': 'BG001'}, {'value': '60190', 'groupId': 'BG002'}, {'value': '85109', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '922', 'groupId': 'BG000'}, {'value': '1438', 'groupId': 'BG001'}, {'value': '11207', 'groupId': 'BG002'}, {'value': '13567', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '10299', 'groupId': 'BG000'}, {'value': '3978', 'groupId': 'BG001'}, {'value': '37892', 'groupId': 'BG002'}, {'value': '52169', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '738', 'groupId': 'BG000'}, {'value': '611', 'groupId': 'BG001'}, {'value': '2945', 'groupId': 'BG002'}, {'value': '4294', 'groupId': 'BG003'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '509', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}, {'value': '948', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1644', 'groupId': 'BG000'}, {'value': '1427', 'groupId': 'BG001'}, {'value': '2657', 'groupId': 'BG002'}, {'value': '5728', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '1169', 'groupId': 'BG000'}, {'value': '1457', 'groupId': 'BG001'}, {'value': '3664', 'groupId': 'BG002'}, {'value': '6290', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '1454', 'groupId': 'BG002'}, {'value': '2113', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2006-06-08', 'resultsFirstSubmitDate': '2014-11-06', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-14', 'studyFirstPostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs', 'timeFrame': 'Within 60 months', 'description': 'Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.'}, {'measure': 'Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs', 'timeFrame': 'Within 60 months', 'description': 'Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drospirenone', 'Safety', 'INAS'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '24576793', 'type': 'DERIVED', 'citation': 'Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception. 2014 Apr;89(4):253-63. doi: 10.1016/j.contraception.2014.01.023. Epub 2014 Feb 4.'}, {'pmid': '21213475', 'type': 'DERIVED', 'citation': 'Dinger J, Do Minh T, Buttmann N, Bardenheuer K. Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen. Obstet Gynecol. 2011 Jan;117(1):33-40. doi: 10.1097/AOG.0b013e31820095a2.'}]}, 'descriptionModule': {'briefSummary': 'The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.', 'detailedDescription': 'Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.\n\nINAS-OC is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen. New users of an OC (starters, switchers without a pill intake break and recurrent users with a pill intake break \\[same or different OC\\]) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women using oral contraceptives', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-ever OC users ("starters")\n* Women switching OC use without a pill intake break ("switchers")\n* Recurrent users with a pill intake break ("recurrent users")\n* Women willing to participate in the active surveillance\n\nExclusion Criteria:\n\n* Women who do not agree to participate\n* Long-term users'}, 'identificationModule': {'nctId': 'NCT00335257', 'briefTitle': 'International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)', 'organization': {'class': 'OTHER', 'fullName': 'Center for Epidemiology and Health Research, Germany'}, 'officialTitle': 'International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)', 'orgStudyIdInfo': {'id': 'ZEG 2005-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Users of OCs containing DRSP'}, {'label': '2', 'description': 'Users of OCs containing other progestins'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Center for Epidemiology and Health Research', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Juergen C Dinger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Epidemiology and Health Research, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Epidemiology and Health Research, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juergen Dinger, MD, PhD', 'investigatorAffiliation': 'Center for Epidemiology and Health Research, Germany'}}}}