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RECRUITING
NCT07061093

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

Sponsor: Ospedale Policlinico San Martino

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

96

Start Date

2023-10-10

Completion Date

2026-01-31

Last Updated

2025-07-11

Healthy Volunteers

Yes

Interventions

DRUG

Ethynyl estradiol and Drospirenone

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

DRUG

Drospirenone

A drospirenone (4mg) only pill

DRUG

Estetrol 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