Hormonal contraceptives' effects on 24-hour blood pressure and heart rate in cycling women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study that follows cycling women who choose either no hormonal contraception or one of several drospirenone-containing contraceptives for at least four consecutive 28-day cycles. Baseline measurements are taken in the follicular phase (days 3–8) including height, weight, vital signs and a 40-hour ambulatory blood pressure recording every 30 minutes from 17:00 to 08:00, and the same recordings are repeated after the fourth cycle. The primary goal is to detect any small changes in 24-hour blood pressure, with a secondary focus on heart rate and the prevalence of dippers versus non-dippers. Eligible participants are healthy, sexually active women aged 18–50 with regular cycles and BMI 18–30 who are willing to use or choose the specified contraceptives and attend in-person monitoring visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ospedale San Martino
  Genova, Ge, Italy Recruiting

Study contacts

• Principal investigator: Angelo Cagnacci, MD, PhD — Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova
• Study coordinator: Angelo Cagnacci
• Email: angelo.cagnacci@unige.it
• Phone: +39 3479715607

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.