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
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;
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;
Subjects will be recruited from outpatient hospital centre for contraception at the University Hospital San Martino of Genova (Italy). Subjects can only be included in the trial if all inclusion criteria are fulfilled, while none of the exclusion criteria are present.
Cohort
Prospective
Ethynyl estradiol and Drospirenone
DrugOral ethynyl estradiol (20 mcg) and 3 mg drospirenone for 24 days and 4 days free of hormones
Drospirenone
DrugA drospirenone (4mg) only pill
Estetrol and Drospirenone
DrugOral estetrol (15 mg) and drospirenone (3 mg) for 24 days and 4 days of interval free of hormone
Rhythmometric evaluation by cosinor analysis
When cosinor analysis is significant, we calculate and record the nadir (time of minimal cosine function; that is, the time in the 24-h period when mean BP and heart rate are at their theoretical minimum). Rhythms are put in phase by considering the nadir as the circadian time 0. The 24-h, daytime, and night-time (3 h before and 3 h after the time of nadir) values are separately evaluated. Assuming a difference in blood pressure o heart rate of 3 mmHg with a standard deviation of the difference of 6 mmHg and setting type I error at 0.05 and type II error at 0.20, 32 women need to be enrolled in each group of treatment.
Comparison of modifications induced by treatments
Identification of the parameters conditioning the eventual BP or heart rate response to treatments
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