Clinical Trial

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

Study acronym: HOLTER CO-PRE
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 11, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT07061093
Lead Sponsor Ospedale Policlinico San Martino
Conditions Cardiovascular System Diseases (& [Cardiac])
Enrollment 96 participants
Start Date 2023-10-10
Primary Completion 2025-11-30 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-11