[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Center for Epidemiology and Health Research, Germany\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100530399","international-active-surveillance-study-safety-of-estrogen-estetrol-e4-contraceptive-study-inas-seecs-100530399",false,"NCT06186271","International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)","INAS-SEECS","Inclusion Criteria:\n\n• New users of E4\u002FDRSP or EE\u002FDRSP or EE\u002FLNG or EE\u002FNGM or EE\u002FNETA\n\nExclusion Criteria:\n\n• Women who have given birth six weeks before treatment starts will be excluded from the study.","FEMALE",{"count":18,"type":19},68100,"ESTIMATED","OBSERVATIONAL","The combined oral contraceptive (COC) containing estetrol (E4) and drospirenone (DRSP) (E4\u002FDRSP) is a novel oral contraceptive containing a fixed dose of E4 (14.2 mg) and DRSP (3 mg). The proposed study will address post-market requirements for E4\u002FDRSP under section 505(o) in response to the Food and Drug Administration (FDA) request.\n\nThe primary objective of the study is to characterize and compare the risks of E4\u002FDRSP with EE\u002FDRSP and E4\u002FDRSP with a pooled cohort of users of EE\u002FLNG, EE\u002FNETA, and EE\u002FNGM combinations (non-DRSP-containing COCs) in a study population of actual users of these preparations under routine clinical practice. The main clinical outcome of interest is VTE.",[23],"Contraception",[25],"Birth control","RECRUITING","2025-08-15",{"date":29,"type":30},"2025-08-20","ACTUAL",{"date":32,"type":30},"2025-04-24",{"date":34,"type":19},"2029-06",{"name":36,"class":37},"Center for Epidemiology and Health Research, Germany","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":38},"100518285","international-active-surveillance-study-native-estrogen-estetrol-e4-safety-study-100518285","NCT06028555","International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study","INAS-NEES","Inclusion Criteria:\n\nNew users of E4\u002FDRSP New users of EE\u002FLNG Germany: only recruitment of study participants who are prescribed the COC within on-label use\n\nExclusion Criteria:\n\n\\-",true,{"count":48,"type":19},101000,"Multinational, comparative, prospective, active surveillance study that follows two cohorts.\n\nThe primary objective of the study is to characterize and compare the risks of E4\u002FDrospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE\u002FLNG) in a study population that is representative of the actual users of these preparations. The main clinical outcome of interest is venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with foetal exposure to E4\u002FDRSP.",[23,51],"Birth Control",{"date":53,"type":30},"2025-08-17",{"date":55,"type":30},"2023-06-28",{"date":57,"type":19},"2028-10-31",{"name":36,"class":37},""]