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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorOspedale Policlinico San Martino

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Ethynyl estradiol and Drospirenone
  • Drospirenone
  • Estetrol and Drospirenone

Treatment groups

No treatment groups listed