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Cardiovascular Impact of the Menstrual Cycle and Contraception - Longitudinal Evaluation

NCT07779447 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-08-21

No results posted yet for this study

Summary

The present study aims to understand the impact of the hormonal cycle and contraceptive pill on cardiac and vascular function, as well as aerobic capacity among women. A well-structured study, minimizing confounding factors, will be conducted with repeated measurements at specific phases of the menstrual cycle to assess the influence of endogenous sexual hormone changes on cardiovascular function and aerobic capacity. The hypothesis is that cyclic changes in oestrogen and progesterone, and to a lesser extent hormonal contraception, could have a subtle but non-negligible influence on cardiovascular function at rest and during exercise.

To test this, 60 healthy young women (18-35 years old) (eumenorrheic, nulliparous, free of any gynaecological/cardiovascular/neurological/osteomuscular/respiratory pathologies, non-smokers, non-obese, not professional athletes), with (30 women) and without hormonal contraception (30 women), will undergo cardiovascular assessments at rest and during exercise (including HRV (heart rate variability) analysis at rest, during effort and after maximal effort, baroreflex and metaboreflex, echocardiography at rest and during effort, blood sample analysis for inflammatory and cardiovascular factors) at the following phases of one identical hormonal cycle: early follicular (menstruation), late follicular (ovulation), and mid-luteal phases.

Assessment of the menstrual phases (menstruation, late follicular phase (FP), and luteal phase (LP)) will be performed using three distinct approaches: monitoring cycle symptoms, daily urinary hormone concentration measurement, and blood hormone analysis during each visit.

Conditions

  • Women Under Hormonal Contraception (Pill) or Without Hormonal Contraception

Sponsors & Collaborators

  • Université Libre de Bruxelles

    lead OTHER

Principal Investigators

  • Vitalie Faoro, Professor · Université Libre de Bruxelles

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • Belgium

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 NCT07779447 on ClinicalTrials.gov