Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study

Recruiting now

Conditions studied: Cardiovascular System Diseases (&Amp; [Cardiac])

In brief

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. The main question aims to answer: \- Does oral contraceptives, estrogen formulations' based combined with drospirenone or the only drospirenone present minr effect on blod pressure and/or on the heart rate? Participants will: * Receive a contraceptive for at least 4 months * 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 * Have a gynecological examination performed at screening and at cycle 4

Key facts

Study ID

NCT07061093

Run by

Ospedale Policlinico San Martino

People needed

96

Starts

2023-10-10

Expected to finish

2026-01-31

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Sexually active women, at risk for pregnancy and willing to use a contraceptive for at least 4 cycles
• Women with regular menstrual cycles with an intermenstrul period between 21 and 35 days
• An age between 18 and 50 years at time of screening
• Body mass index ≥18 and ≤30;
• Good physical and mental health;
• Choose either no hormonal contraception or one of the specific contraceptives under investigation
• Willing to give informed consent in writing

You may not qualify if…

• Contraindications for contraceptive steroids:
• Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;
• Precence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris);
• History of migraine with focal neurological symptoms;
• Diabetes mellitus with vascular involvement;
• The presence of a severe or multiple risck factor(s) for venous or arterial thrombosis (to be judged by the (sub)-investigator).
• 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< 40 years o); obesity (body mass index over 30 kg/m2); 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;
• Severe dyslipoproteinemia
• Blood pressure above 140/90 mmHg
• 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);
• Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
• Presence or history of liver tumors (benign or malignant);
• Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Hypersensitivity to the active substances or to any of the excipients of the investigational product
• An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia (CIN), SIL, carcinoma in situ, invasive carcinoma) at the screening evaluation
• Clinically relevant abnormal laboratory data as judged by the investigator;
• Post-partum (6 months from delivery)
• Breastfeeding or 2 months from breastfeeding ending
• 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);
• Administration of any other investigational drugs and/or participation in other clinical trial in the last 2 months.
• Present use of any oral contraceptive.

Where it is running

• Ospedale San Martino — Genova, GE, Italy (enrolling)

Full record on ClinicalTrials.gov

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