[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-system-diseases-amp-cardiac\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-system-diseases-amp-cardiac":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":22,"type":23},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",[27],"Cardiovascular System Diseases (&Amp; [Cardiac])","RECRUITING","2025-07-02",{"date":31,"type":32},"2025-07-11","ACTUAL",{"date":34,"type":32},"2023-10-10",{"date":36,"type":23},"2026-01-31",{"name":38,"class":39},"Ospedale Policlinico San Martino","OTHER"]