[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597638":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":7,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":7,"studyType":64,"phases":7,"briefSummary":65,"conditions":66,"keywords":7,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Ospedale Policlinico San Martino","OTHER",null,[9,13,16],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Ethynyl estradiol and Drospirenone","Oral ethynyl estradiol (20 mcg) and 3 mg drospirenone for 24 days and 4 days free of hormones",{"type":10,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"Drospirenone","A drospirenone (4mg) only pill",{"type":10,"name":17,"description":18,"armGroupLabels":7,"otherNames":7},"Estetrol and Drospirenone","Oral estetrol (15 mg) and drospirenone (3 mg) for 24 days and 4 days of interval free of hormone",[20],{"name":21,"affiliation":22,"role":23},"Angelo Cagnacci, MD, PhD","Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":7,"email":29},"Angelo Cagnacci","CONTACT","+39 3479715607","angelo.cagnacci@unige.it",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Ospedale San Martino","RECRUITING","Genova","GE","16132","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],11.87211,45.21604,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":28,"phoneExt":7,"email":29},{"type":23,"investigatorFullName":26,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Full Professor Obstetric and Gynecology - Director Academic Unit of Obstetrics and Gynecology","100597638","prospective-evaluation-on-the-role-exerted-by-hormonal-contraceptives-on-24-h-blood-pressure-a-prospective-observational-study-100597638",false,"NCT07061093","Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study","Valutazione Prospettica Sul Ruolo Esercitato Dai Contraccettivi Ormonali Sulla Pressione Delle 24 Ore","HOLTER CO-PRE","Inclusion Criteria:\n\n* Sexually active women, at risk for pregnancy and willing to use a contraceptive for at least 4 cycles\n* Women with regular menstrual cycles with an intermenstrul period between 21 and 35 days\n* An age between 18 and 50 years at time of screening\n* Body mass index ≥18 and ≤30;\n* Good physical and mental health;\n* Choose either no hormonal contraception or one of the specific contraceptives under investigation\n* Willing to give informed consent in writing\n\nExclusion Criteria:\n\n* Contraindications for contraceptive steroids:\n\n  * Presence or a history of venous or arterial thrombotic\u002Fthromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;\n  * Precence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris);\n  * History of migraine with focal neurological symptoms;\n  * Diabetes mellitus with vascular involvement;\n  * The presence of a severe or multiple risck factor(s) for venous or arterial thrombosis (to be judged by the (sub)-investigator).\n\n    e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at an age\\\u003C 40 years o); obesity (body mass index over 30 kg\u002Fm2); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery any surgery to the legs, or major trauma (until two weeks after full remobilization); systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis); sickle cell disease;\n  * Severe dyslipoproteinemia\n  * Blood pressure above 140\u002F90 mmHg\n  * Known hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-lll-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);\n  * Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;\n  * Presence or history of severe hepatic disease as long as liver function values have not returned to normal;\n  * Presence or history of liver tumors (benign or malignant);\n  * Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);\n  * Undiagnosed vaginal bleeding\n  * Known or suspected pregnancy\n  * Hypersensitivity to the active substances or to any of the excipients of the investigational product\n* An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), SIL, carcinoma in situ, invasive carcinoma) at the screening evaluation\n* Clinically relevant abnormal laboratory data as judged by the investigator;\n* Post-partum (6 months from delivery)\n* Breastfeeding or 2 months from breastfeeding ending\n* Present use or use in the last 2 months of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hipericum perforatum (St John's Wort);\n* Administration of any other investigational drugs and\u002For participation in other clinical trial in the last 2 months.\n* Present use of any oral contraceptive.",true,"FEMALE","18 Years","50 Years",{"count":62,"type":63},96,"ESTIMATED","OBSERVATIONAL","This study aims to assess the effect of different hormonal contraceptives on 24-h blood pressure in cycling women aged 18-50 years of age.\n\nThe main question aims to answer:\n\n\\- Does oral contraceptives, estrogen formulations' based combined with drospirenone or the only drospirenone present minr effect on blod pressure and\u002For on the heart rate?\n\nParticipants will:\n\n* Receive a contraceptive for at least 4 months\n* Visit the clinic between days 3 and 8 of the menstrual cycle for recording of vital signs and 40 hours-blood pressure monitoring every 30 min from 17.00 to 8.00 of the following second day\n* Have a gynecological examination performed at screening and at cycle 4",[67],"Cardiovascular System Diseases (&Amp; [Cardiac])","2025-07-02",{"date":70,"type":71},"2025-07-11","ACTUAL",{"date":73,"type":71},"2023-10-10",{"date":75,"type":63},"2026-01-31",{"name":5,"class":6},1]