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

Valutazione Prospettica Sul Ruolo Esercitato Dai Contraccettivi Ormonali Sulla Pressione Delle 24 Ore

See if different drospirenone-containing hormonal contraceptives change 24-hour blood pressure and heart rate in women aged 18–50.

Quick facts

• Study type: Observational
• Enrollment: 96 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Ospedale Policlinico San Martino (Academic / other)
• Locations: 1 site (Genova, GE)
• Trial ID: NCT07061093 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Sexually active, menstruating women aged 18–50 with regular 21–35 day cycles, BMI between 18 and 30, and willing to use a contraceptive for at least four cycles and undergo ambulatory blood pressure monitoring.

Not a fit: Women with contraindications to hormonal steroids, a history of thrombotic disease, migraine with focal neurological symptoms, diabetes with vascular involvement, irregular cycles, or those unwilling to complete the monitoring or follow-up are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians pick contraceptives that have smaller effects on blood pressure and heart rate, improving cardiovascular safety for women.

How similar studies have performed: Prior studies have reported small blood pressure increases with some combined oral contraceptives, but the specific impact of newer estrogen formulations and drospirenone-alone regimens is less well established.

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.

Where this trial is running

Genova, GE

• 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

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