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

Launched by OSPEDALE POLICLINICO SAN MARTINO · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different types of hormonal birth control affect blood pressure and heart rate over a 24-hour period in women aged 18 to 50 who have regular menstrual cycles. The goal is to find out if certain birth control pills, especially those containing estrogen combined with drospirenone or drospirenone alone, cause any changes in blood pressure or heart rate.

Women who are eligible to join are those who are sexually active and at risk of pregnancy, willing to use one of the study’s birth control methods for at least four months, have regular periods, are in good health, and have a body mass index (BMI) between 18 and 30. Participants will visit the clinic early in their menstrual cycle for health checks, including a gynecological exam, and will wear a blood pressure monitor that checks their blood pressure every 30 minutes overnight. The study excludes women with certain health conditions, such as high blood pressure, blood clot risks, or recent use of other hormonal contraceptives. This study aims to help women and doctors better understand how birth control might impact heart health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• * 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.