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

NCT07061093 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2025-07-11

No results posted yet for this study

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

Conditions

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

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

Sponsors & Collaborators

  • Ospedale Policlinico San Martino

    lead OTHER

Principal Investigators

  • Angelo Cagnacci, MD, PhD · Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2025-11-30
Completion
2026-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061093 on ClinicalTrials.gov