Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT00214903
Status:
COMPLETED
Last Update Posted:
2014-12-01
First Post:
2005-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dinger@zeg-berlin.de', 'phone': '+49 (0) 30 945 101 20', 'title': 'Juergen Dinger, MD, PhD', 'organization': 'Center for Epidemiology and Health Research, Germany'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'In non-experimental studies like EURAS-HRT 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 8.5 years.', 'description': 'Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'DRSP/E2', 'description': 'Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol', 'otherNumAtRisk': 10043, 'otherNumAffected': 0, 'seriousNumAtRisk': 10043, 'seriousNumAffected': 707}, {'id': 'EG001', 'title': 'ooccHRT', 'description': 'Users of other oral continuous combined HRT preparations containing other progestogens', 'otherNumAtRisk': 13384, 'otherNumAffected': 0, 'seriousNumAtRisk': 13384, 'seriousNumAffected': 1998}, {'id': 'EG002', 'title': 'ooHRT', 'description': 'Users of oral but not continuous combined HRT preparations', 'otherNumAtRisk': 4113, 'otherNumAffected': 0, 'seriousNumAtRisk': 4113, 'seriousNumAffected': 576}, {'id': 'EG003', 'title': 'Non-oral HRT', 'description': 'Users of non-oral HRT preparations', 'otherNumAtRisk': 3057, 'otherNumAffected': 0, 'seriousNumAtRisk': 3057, 'seriousNumAffected': 508}], 'seriousEvents': [{'term': 'Infectious diseases', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Neoplasms, malignant and benign', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 91, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 248, 'numAffected': 248}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 62, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 58, 'numAffected': 58}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Diseases of the blood and bloodforming organs', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Endocrine diseases', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Psychiatric and neurological disorders', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Eye', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Ear', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Cardiovascular system', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 135, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 542, 'numAffected': 542}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 155, 'numAffected': 155}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 130, 'numAffected': 130}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Respiratory system', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 78, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Digestive system', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 90, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 237, 'numAffected': 237}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 69, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 68, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Skin', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Muscoskeletal system & connective tissue', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 117, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 285, 'numAffected': 285}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Genitourinary system', 'notes': 'This adverse event term also includes renal and urinary disorders. Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 111, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}, {'term': 'Injury, poisoning, accidents, etc.', 'notes': 'Prespecified category; a further breakdown by sub-categories was only planned in case that the results indicated an increased risk for DRSP/E2.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10043, 'numEvents': 93, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 13384, 'numEvents': 226, 'numAffected': 226}, {'groupId': 'EG002', 'numAtRisk': 4113, 'numEvents': 72, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 3057, 'numEvents': 64, 'numAffected': 64}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-10'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10043', 'groupId': 'OG000'}, {'value': '13384', 'groupId': 'OG001'}, {'value': '4113', 'groupId': 'OG002'}, {'value': '3057', 'groupId': 'OG003'}]}, {'units': 'Women-years', 'counts': [{'value': '13,714', 'groupId': 'OG000'}, {'value': '31,938', 'groupId': 'OG001'}, {'value': '9,253', 'groupId': 'OG002'}, {'value': '7,785', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP/E2', 'description': 'Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol'}, {'id': 'OG001', 'title': 'ooccHRT', 'description': 'Users of other oral continuous combined HRT preparations containing other progestogens'}, {'id': 'OG002', 'title': 'ooHRT', 'description': 'Users of oral but not continuous combined HRT preparations'}, {'id': 'OG003', 'title': 'Non-oral HRT', 'description': 'Users of non-oral HRT preparations'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], '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, region, and HRT user status.', 'groupDescription': 'Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.'}], 'paramType': 'NUMBER', 'timeFrame': 'within 8.5 years', 'description': 'Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Women-years', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.'}, {'type': 'PRIMARY', 'title': 'Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10043', 'groupId': 'OG000'}, {'value': '13384', 'groupId': 'OG001'}, {'value': '4113', 'groupId': 'OG002'}, {'value': '3057', 'groupId': 'OG003'}]}, {'units': 'Women-years', 'counts': [{'value': '13,714', 'groupId': 'OG000'}, {'value': '31,938', 'groupId': 'OG001'}, {'value': '9,253', 'groupId': 'OG002'}, {'value': '7,785', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP/E2', 'description': 'Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol'}, {'id': 'OG001', 'title': 'ooccHRT', 'description': 'Users of other oral continuous combined HRT preparations containing other progestogens'}, {'id': 'OG002', 'title': 'ooHRT', 'description': 'Users of oral but not continuous combined HRT preparations'}, {'id': 'OG003', 'title': 'Non-oral HRT', 'description': 'Users of non-oral HRT preparations'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.8', 'estimateComment': 'Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.', 'groupDescription': 'Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.'}], 'paramType': 'NUMBER', 'timeFrame': 'within 8.5 years', 'description': 'Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Women-years', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DRSP/E2', 'description': 'Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol'}, {'id': 'FG001', 'title': 'ooccHRT', 'description': 'Users of other oral continuous combined HRT preparations containing other progestogens'}, {'id': 'FG002', 'title': 'ooHRT', 'description': 'Users of oral but not continuous combined HRT preparations'}, {'id': 'FG003', 'title': 'Non-oral HRT', 'description': 'Users of non-oral HRT preparations'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10043'}, {'groupId': 'FG001', 'numSubjects': '13384'}, {'groupId': 'FG002', 'numSubjects': '4113'}, {'groupId': 'FG003', 'numSubjects': '3057'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10043'}, {'groupId': 'FG001', 'numSubjects': '13384'}, {'groupId': 'FG002', 'numSubjects': '4113'}, {'groupId': 'FG003', 'numSubjects': '3057'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 31,321 patients were recruited for the EURAS HRT study. 724 patients were excluded due to protocol violations (e.g., patient agreed to participate but never started to use the new HRT preparation or continued to use a previously prescribed preparation).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10043', 'groupId': 'BG000'}, {'value': '13384', 'groupId': 'BG001'}, {'value': '4113', 'groupId': 'BG002'}, {'value': '3057', 'groupId': 'BG003'}, {'value': '30597', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'DRSP/E2', 'description': 'Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol'}, {'id': 'BG001', 'title': 'ooccHRT', 'description': 'Users of other oral continuous combined HRT preparations containing other progestogens'}, {'id': 'BG002', 'title': 'ooHRT', 'description': 'Users of oral but not continuous combined HRT preparations'}, {'id': 'BG003', 'title': 'Non-oral HRT', 'description': 'Users of non-oral HRT preparations'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '52.9', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '54.0', 'spread': '7.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10043', 'groupId': 'BG000'}, {'value': '13384', 'groupId': 'BG001'}, {'value': '4113', 'groupId': 'BG002'}, {'value': '3057', 'groupId': 'BG003'}, {'value': '30597', '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': 'Europe', 'categories': [{'measurements': [{'value': '10043', 'groupId': 'BG000'}, {'value': '13384', 'groupId': 'BG001'}, {'value': '4113', 'groupId': 'BG002'}, {'value': '3057', 'groupId': 'BG003'}, {'value': '30597', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'This study was conducted in seven European countries: Austria, Belgium, Germany, Italy, the Netherlands, Spain, and Turkey. 23,025 participants were eligibly enrolled in Central Europe, and 7,572 participants in Southern Europe.', 'unitOfMeasure': 'participants'}], 'populationDescription': "At baseline, 33% of women were using DRSP/E2, 44% were using ooccHRT, 13% were using ooHRT, and 10% 'Non-oral HRT'. These proportions only partially reflect the overall exposure in each cohort (AT population) because market authorization for DRSP/E2 was delayed by more than 1.5 years."}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30597}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2005-09-19', 'resultsFirstSubmitDate': '2014-11-06', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-06', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)', 'timeFrame': 'within 8.5 years', 'description': 'Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.'}, {'measure': 'Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)', 'timeFrame': 'within 8.5 years', 'description': 'Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postmenopause', 'HRT'], 'conditions': ['Menopausal Symptoms']}, 'referencesModule': {'references': [{'pmid': '27174159', 'type': 'DERIVED', 'citation': 'Dinger J, Bardenheuer K, Heinemann K. Drospirenone plus estradiol and the risk of serious cardiovascular events in postmenopausal women. Climacteric. 2016 Aug;19(4):349-56. doi: 10.1080/13697137.2016.1183624. Epub 2016 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the active surveillance study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users for up to 8.5 years.', 'detailedDescription': 'The safety of a novel drug product containing a new chemical entity should be assessed in an extensive post marketing safety surveillance program. It is also prudent to assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to the special pharmacological characteristics of the novel drug product. Differentiating between the inherent background population risk and a potential incremental risk due to treatment is often challenging. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavour.\n\nThe primary objective of the study, the European Active Surveillance Study of Women taking HRT (EURAS-HRT), is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products. This active surveillance study will assess pertinent cardiovascular outcomes in new HRT users over a study period of up to 8.5 years. Also, all other serious adverse events will be reported.\n\nThe new drug product under surveillance in the EURAS - HRT study contains the novel synthetic progestagen drospirenone (DRSP) combined with estradiol.\n\nAs estrogen/progestagen combinations increase the risk for thromboembolism, all new drug products that contain a novel estrogen or progestagen should be investigated for their influence on venous and arterial thromboembolic events rates. A large, prospective, controlled cohort study of OC users (EURAS OC study), which compared DRSP-containing OC users with other OC users, demonstrated that DRSP is not associated with an increased incidence for any of the above-mentioned adverse events in OC users. However, because OC users are two to three decades younger than the typical HRT user the results of the OC study can only partially be extrapolated to older age groups.\n\nThe participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes (including cancer) occurring during the observational period will be evaluated additionally. Reported serious adverse events will be validated and analyzed. As study participants may switch from oral continuous combined products to other oral or non-oral HRT products the outcomes for these preparation are recorded too. However, these results represent not the scientific focus of the study.\n\nBased on experience obtained in previous HRT studies, complex sources of bias and confounding are expected. Multivariate methods will therefore be used to adjust for confounding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 40 or more years using HRT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women aged 40 or more years who started use of a new oral HRT at the time of inclusion in the study\n\nExclusion Criteria:\n\n* Women who do not consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT00214903', 'briefTitle': 'European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)', 'organization': {'class': 'OTHER', 'fullName': 'Center for Epidemiology and Health Research, Germany'}, 'officialTitle': 'European Active Surveillance Study of Women Taking HRT', 'orgStudyIdInfo': {'id': 'ZEG 2000_3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'New users of oral continuous combined HRT containing drospirenone'}, {'label': '2', 'description': 'New users of oral continuous combined HRT containing other progestagens'}]}, '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 Dinger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZEG, Invalidenstrasse 115, 10115 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'}}}}