Loading clinical trials...
Loading clinical trials...
Valutazione Prospettica Sul Ruolo Esercitato Dai Contraccettivi Ormonali Sulla Pressione Delle 24 Ore
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
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-
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
Yes
Ospedale San Martino
Genova, GE, Italy
Start Date
October 10, 2023
Primary Completion Date
November 30, 2025
Completion Date
January 31, 2026
Last Updated
July 11, 2025
96
ESTIMATED participants
Ethynyl estradiol and Drospirenone
DRUG
Drospirenone
DRUG
Estetrol and Drospirenone
DRUG
Lead Sponsor
Ospedale Policlinico San Martino
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions