Actively Recruiting
Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study
Led by Ospedale Policlinico San Martino · Updated on 2025-07-11
96
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sexually active women at risk of pregnancy willing to use a contraceptive for at least 4 cycles
- Women with regular menstrual cycles with intervals between 21 and 35 days
- Age between 18 and 50 years at screening
- Body mass index between 18 and 30
- Good physical and mental health
- Choose either no hormonal contraception or one of the specified contraceptives
- Willing to provide written informed consent
You will not qualify if you...
- History or presence of venous or arterial blood clots, including deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- History of transient ischemic attack or angina
- Migraine with focal neurological symptoms
- Diabetes with vascular problems
- Severe or multiple risk factors for blood clots such as smoking, obesity, family history, high blood pressure, dyslipoproteinemia, valvular heart disease, atrial fibrillation, prolonged immobility, major surgery, systemic lupus erythematosus, certain chronic inflammatory diseases, or sickle cell disease
- Severe dyslipoproteinemia
- Blood pressure above 140/90 mmHg
- Known hereditary or acquired conditions increasing risk of blood clots
- Pancreatitis linked to severe hypertriglyceridemia
- Severe liver disease or liver tumors
- Known or suspected hormone-related cancers
- Undiagnosed vaginal bleeding
- Known or suspected pregnancy
- Allergy to study medications
- Abnormal cervical smear at screening
- Clinically significant abnormal laboratory results
- Postpartum less than 6 months
- Breastfeeding or within 2 months after stopping breastfeeding
- Use of certain medications that interfere with hormones or metabolism within 2 months
- Participation in other clinical trials or use of investigational drugs within 2 months
- Current use of any oral contraceptive
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ospedale San Martino
Genova, GE, Italy, 16132
Actively Recruiting
Research Team
A
Angelo Cagnacci
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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