[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518285":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":14,"centralContacts":19,"locations":28,"responsibleParty":45,"collaborators":47,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":10,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Center for Epidemiology and Health Research, Germany","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Estetrol\u002Fdrospirenone (E4\u002FDRSP)",null,"Users: Starters and re-starters",{"label":13,"type":10,"description":11,"interventionNames":10},"Ethinyl estradiol\u002Flevonorgestrel (EE\u002FLNG)",[15],{"name":16,"affiliation":17,"role":18},"Klaas Heinemann, Dr.","ZEG Berlin GmbH","PRINCIPAL_INVESTIGATOR",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Armin Papkalla, Dr.","CONTACT","+49 30 945 101 20","a.papkalla@zeg-berlin.de",{"name":26,"role":22,"phone":23,"phoneExt":10,"email":27},"Silke Zimmermann, Dr.","s.zimmermann@zeg-berlin.de",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Berlin Center for Epidemiology and Health Research","RECRUITING","Berlin","State of Berlin","10115","Germany","DE",{"type":38,"coordinates":39},"Point",[40,41],13.41053,52.52437,{"lat":41,"lon":40},[44],{"name":21,"role":22,"phone":10,"phoneExt":10,"email":24},{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[48,51],{"name":49,"class":50},"Estetra","INDUSTRY",{"name":52,"class":50},"Gedeon Richter Plc.","100518285","international-active-surveillance-study-native-estrogen-estetrol-e4-safety-study-100518285",false,"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,"FEMALE",{"count":63,"type":64},101000,"ESTIMATED","OBSERVATIONAL","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.",[68,69],"Contraception","Birth Control","2025-08-15",{"date":72,"type":73},"2025-08-17","ACTUAL",{"date":75,"type":73},"2023-06-28",{"date":77,"type":64},"2028-10-31",{"name":5,"class":6},1]