[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530399":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":32,"responsibleParty":49,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":10,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Center for Epidemiology and Health Research, Germany","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"E4\u002FDRSP",null,"E4\u002FDRSP: estetrol\u002Fdrospirenone\n\nnew users (starters and restarters with at least two months break)",{"label":13,"type":10,"description":14,"interventionNames":10},"EE\u002FDRSP","EE\u002FDRSP: ethinyl estradiol\u002Fdrospirenone\n\nnew users (starters and restarters with at least two months break)",{"label":16,"type":10,"description":17,"interventionNames":10},"EE\u002FLNG and EE\u002FNETA and EE\u002FNGM","EE\u002FLNG: ethinyl estradiol\u002Flevonorgestrel\n\nEE\u002FNETA: ethinyl estradiol\u002Fnorethisterone\u002Fnorethindrone acetate\n\nEE\u002FNGM: ethinyl estradiol\u002Fnorgestimate\n\nnew users (starters and restarters with at least two months break)",[19],{"name":20,"affiliation":21,"role":22},"Klaas Heinemann, Dr.","ZEG Berlin GmbH","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Armin Papkalla, Dr.","CONTACT","+49 30 945 101 20","a.papkalla@zeg-berlin.de",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},"Silke Zimmermann, Dr.","s.zimmermann@zeg-berlin.de",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Berlin Center for Epidemiology and Health Research","RECRUITING","Berlin","State of Berlin","10115","Germany","DE",{"type":42,"coordinates":43},"Point",[44,45],13.41053,52.52437,{"lat":45,"lon":44},[48],{"name":25,"role":26,"phone":10,"phoneExt":10,"email":28},{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[52,55],{"name":53,"class":54},"Estetra","INDUSTRY",{"name":56,"class":54},"Gedeon Richter Plc.","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":66,"type":67},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.",[71],"Contraception",[73],"Birth control","2025-08-15",{"date":76,"type":77},"2025-08-20","ACTUAL",{"date":79,"type":77},"2025-04-24",{"date":81,"type":67},"2029-06",{"name":5,"class":6},1]