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

NCT07061093 | Recruiting

• 1 other identifier: 12674
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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])

Outcome Measures

Primary Outcomes (1)

• Rhythmometric evaluation by cosinor analysis

  When cosinor analysis is significant, we calculate and record the nadir (time of minimal cosine function; that is, the time in the 24-h period when mean BP and heart rate are at their theoretical minimum). Rhythms are put in phase by considering the nadir as the circadian time 0. The 24-h, daytime, and night-time (3 h before and 3 h after the time of nadir) values are separately evaluated. Assuming a difference in blood pressure o heart rate of 3 mmHg with a standard deviation of the difference of 6 mmHg and setting type I error at 0.05 and type II error at 0.20, 32 women need to be enrolled in each group of treatment.

  From starting of the treatment to the end of it at 4 months

Secondary Outcomes (2)

• Comparison of modifications induced by treatments

  From starting of the treatment to the end of it at 4 months

• Identification of the parameters conditioning the eventual BP or heart rate response to treatments

  From starting of the treatment to the end of it at 4 months

Interventions

Ethynyl estradiol and Drospirenone DRUG

Oral ethynyl estradiol (20 mcg) and 3 mg drospirenone for 24 days and 4 days free of hormones

Drospirenone DRUG

A drospirenone (4mg) only pill

Estetrol and Drospirenone DRUG

Oral estetrol (15 mg) and drospirenone (3 mg) for 24 days and 4 days of interval free of hormone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from outpatient hospital centre for contraception at the University Hospital San Martino of Genova (Italy). Subjects can only be included in the trial if all inclusion criteria are fulfilled, while none of the exclusion criteria are present.

You may qualify if:

• Sexually active women, at risk for pregnancy and willing to use a contraceptive for at least 4 cycles
• Women with regular menstrual cycles with an intermenstrul period between 21 and 35 days
• An age between 18 and 50 years at time of screening
• Body mass index ≥18 and ≤30;
• Good physical and mental health;
• Choose either no hormonal contraception or one of the specific contraceptives under investigation
• Willing to give informed consent in writing

You may not qualify if:

• Contraindications for contraceptive steroids:
• Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;
• Precence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris);
• History of migraine with focal neurological symptoms;
• Diabetes mellitus with vascular involvement;
• The presence of a severe or multiple risck factor(s) for venous or arterial thrombosis (to be judged by the (sub)-investigator).
• e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at an age\< 40 years o); obesity (body mass index over 30 kg/m2); dyslipoproteinaemia; hypertension, migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery any surgery to the legs, or major trauma (until two weeks after full remobilization); systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis); sickle cell disease;
• Severe dyslipoproteinemia
• Blood pressure above 140/90 mmHg
• Known hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin-lll-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
• Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
• Presence or history of liver tumors (benign or malignant);
• Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);
• Undiagnosed vaginal bleeding

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Ospedale San Martino

Genova, GE, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ethinyl Estradiol; drospirenone; drospirenone and estetrol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Angelo Cagnacci, MD, PhD

  Clinica Ostetrica e Ginecologica, IRCCS-Ospedale San Martino di Genova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Cagnacci

CONTACT

+39 3479715607; angelo.cagnacci@unige.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetric and Gynecology - Director Academic Unit of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: October 10, 2023
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

IT (1)