NCT07061093

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 96 (estimated)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

Aim of this study is to investigate a possible minor effect on blood pressure and, secondarily, on heart rate of oral contraceptives based on the new estrogen formulations combined with drospirenone or with the administration of drospirenone alone. The seecondary objectives are: * To evaluate modification of prevalence of dippers and non-dippers for each treatment * To evaluate 24-h variation of Heart Rate For all women participating in this trial the total treatment period is at least 4 consecutive cycles of 28 days each. The experimental flow will have a: * Screening phase: inform the subject, orally and in writing, about the purpose, procedures, and general risks of participating in the trial and collect all data required * Baseline phase: the investigation is performed in the follicular phase between days 3 and 8 of the menstrual cycle; recording of height, body weight and blood pressure, and an ulterior 40 hours-blood pressure monitoring -Cycle 4 phase: in which the recording made during the Baseline phase will be repeated-

Conditions

• Cardiovascular System Diseases (&Amp; [Cardiac])

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-11-30
• Completion: 2026-01-31
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: Italy