RecruitingNCT07061093

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

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


Sponsor

Ospedale Policlinico San Martino

Enrollment

96 participants

Start Date

Oct 10, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Drospirenone, a drug called Estetrol and Drospirenone, and others for people with cardiovascular system diseases (& [cardiac]). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEthynyl estradiol and Drospirenone

Oral ethynyl estradiol (20 mcg) and 3 mg drospirenone for 24 days and 4 days free of hormones

DRUGDrospirenone

A drospirenone (4mg) only pill

DRUGEstetrol and Drospirenone

Oral estetrol (15 mg) and drospirenone (3 mg) for 24 days and 4 days of interval free of hormone


Locations(1)

Ospedale San Martino

Genova, GE, Italy

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NCT07061093