[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634213":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":40,"responsibleParty":45,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":40,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":40,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":40,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":40},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"E4-drospirenone","EXPERIMENTAL","Estetrol-drospirenone",[13],"Drug: Estetrol-drospirenone",{"label":15,"type":16,"description":17,"interventionNames":18},"EE-levonorgestrel","ACTIVE_COMPARATOR","Ethinylestradiol-levonorgestrel",[19],"Drug: Ethinylestradiol-levonorgestrel",[21,27],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Estetrol 15mg + drospirenone 3mg",[9],[26],"Alyssa",{"type":22,"name":17,"description":28,"armGroupLabels":29,"otherNames":30},"Ethinylestradiol 30mcg + levonorgestrel 150mcg",[15],[31],"Microgynon",[33],{"name":34,"affiliation":5,"role":35},"Raymond HW Li, MD, FRCOG","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+852 22554517",null,"raymondli@hku.hk",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Jennifer KY Ko, MBBS, FRCOG","jenko@hku.hk",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Dr. Hang Wun Raymond Li","Clinical Associate Professor",[50],{"name":51,"class":6},"The Family Planning Association of Hong Kong","100634213","phase-3-arterial-vascular-effects-of-estetrol-drospirenone-combined-oral-contraceptive-pill-100634213",false,"NCT07536763","Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill","Effect of Estetrol-drospirenone Combined Oral Contraceptive Pill on Arterial Vascular Risks","Inclusion Criteria:\n\n* Aged between 18 and 49 years inclusive\n* Considering to use the COC pill for contraception or treatment of menstrual disorders\n\nExclusion Criteria:\n\n* Being diagnosed with menopause\n* Having contraindications to COC, including (but not confined to) hypertension, diabetes mellitus with complications, history of ischaemic heart disease, thromboembolism, stroke, severe liver disease, oestrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers aged 35 years or above, or having body mass index \\>=35 kg\u002Fm2\n* Planning to get pregnant in the coming 1 year\n* Having been pregnant in the past 3 months\n* Having been on COC or hormone replacement therapy in the past 3 months (those who had been on these agents can stop these for 3 months as wash-out period before being recruited; this concurs with other similar studies in the literature)\n* Having been on anti-hypertensive, anti-diabetic or lipid-lowering agents in the past 3 months\n* Refusal to randomization",true,"FEMALE","18 Years","49 Years",{"count":64,"type":65},98,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","The goals of this clinical trial are to investigate the effect of the estetrol (E4)-drospirenone combined oral contraceptive (COC) pill on flow-mediated dilatation (FMD) of the brachial artery and pulse wave velocity (PWV), in comparison to the ethinylestradiol (EE)-levonorgestrel COC pill, and to compare their respective effects on blood pressure, chronic inflammatory markers, as well as glycaemic and lipid indices.\n\nThe main questions it aims to answer are:\n\nDoes E4-drospirenone COC have significantly smaller effects then EE-levonorgestrel COC on FMD, PWV, blood pressure, chronic inflammatory markers, as well as glycemic and lipid indices.\n\nResearchers will compare E4-drospirenone to EE-levonorgestrel to see if the former has lower arterial vascular and metabolic risks.\n\nParticipants will:\n\n* be randomised to take E4-drospirenone or EE-levonorgestrel COC pill according to product insert;\n* visit the clinic at baseline and 6 and 12 months post-recruitment for checkups and tests",[71],"Contraception",[11,17,73,74,75],"Combined oral contraceptives","Arterial risks","Metabolic risks","NOT_YET_RECRUITING","2026-04-24",{"date":79,"type":80},"2026-04-27","ACTUAL",{"date":82,"type":65},"2026-07",{"date":84,"type":65},"2029-06",{"name":47,"class":6}]