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Women Under Hormonal Contraception (Pill) or Without Hormonal ContraceptionCICCLENCT07779447

Cardiovascular Impact of the Menstrual Cycle and Contraception - Longitudinal Evaluation

An observational study of Women Under Hormonal Contraception (Pill) or Without Hormonal Contraception, run by Université Libre de Bruxelles at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Type of treatment
Pill or oral medicine
How many people
60 participants
Where
1 siteBelgium
Study dates
1 Feb 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: 60 healthy women : 30 healthy youg (18-35 ans) female with hormonal contraception (pill), and 30 healthy women without hormonal contraception will be recruted, matched for age, sex, body mass index (BMI) and physical activity level. All women will have regular cycles with ovulation assessed (between 26 and 34 days with maximum 2 to 3 days of difference between cycles) be eumenorrheic, nulliparous, free of any gynaecological/cardiovascular/neurologic/osteomuscular/respiratory pathologies, non-smoker, non-obese (BMI between 18.5 and 25) and drug-free.

Who may be able to join

  • Female, aged 18 to 35 years.
  • Healthy participant.
  • Either;
  • Current user of hormonal oral contraception for at least 3 months prior to enrollment; or
  • Naturally cycling woman not using hormonal contraception.
  • Regular menstrual cycles between 26 and 34 days, with no more than 2-3 days variation between consecutive cycles.
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  • Evidence of ovulation during the menstrual cycle monitoring period.
  • Nulliparous.
  • Body mass index (BMI) between 18.5 and 25.0 kg/m².
  • Able and willing to comply with all study procedures and visits.

Who cannot join

  • Current smoker or use of nicotine-containing products.
  • Pregnancy or breastfeeding.
  • History or presence of gynecological disorders.
  • History or presence of cardiovascular disease.
  • History or presence of neurological disease.
  • History or presence of respiratory disease.
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  • History or presence of musculoskeletal disorders that may affect exercise performance.
  • Obesity (BMI >25.0 kg/m²).
  • Use of medications known to affect cardiovascular, respiratory, autonomic, or hormonal function.
  • Inability or unwillingness to abstain from alcohol and caffeine for 72 hours before each experimental session.

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Université Libre de Bruxelles - Campus Erasme - Faculté des Sciences de la Motricité Humaine - Laboratoire de Physiologie Cardiorespiratoire, Exercice et Nutrition

    Anderlecht, Brussels Capital, 1070

Other trials in Belgium

About this study

Official title: Effets of the Hormonal Cycle and Contraception on Cardiovascular System and Sport Performance

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.

Read the detailed description

Recently, Caroline Criado Perez highlighted gender bias in her book "Invisible Women: Exposing Data Bias in a World Designed for Men". Perez sheds light on the pervasive bias against women, affecting various aspects of their lives in a world predominantly shaped by male-centric data. Town planning, public transport, car seat belt design, toilet facilities, pension policies, and smartphone tracking apps are among the areas revealing systemic disadvantages for women.

Moreover, women are also disadvantaged in terms of their own health. Menstrual cycle effects have been found for antipsychotics, antihistamines, antibiotics, and heart medications, meaning that dosages can sometimes be inappropriate. Sex differences in pharmacodynamics may also affect cardiovascular medications. This is not without consequences; for example, digoxin therapy is associated with an increase in all-cause mortality among women.

These issues persist because scientific studies dedicated to women are significantly under-represented in research. Sport science research is no exception. While women's sport is slowly but increasingly becoming accessible and popular worldwide, women remain under-represented in scientific studies on sports performance. This is illustrated by the fact that among three major Sports and Exercise Medicine journals, 1,382 articles involve a total of 6,076,580 participants, including 2,366,968 (39%) female participants and 3,709,612 (61%) male participants, with only 4-13% of the articles incorporating female participants exclusively. A primary justification for the lack of female inclusion in sports science research is the limited understanding of hormonal variations during the menstrual cycle.

The gap in female representation in sports science must be addressed. The present study aims to improve understanding of the impact of the hormonal cycle on sports performance among women with and without hormonal contraception. A deeper understanding of hormonal effects on performance may offer widespread benefits for women globally. The menstrual cycle is the sequence of hormonal and physiological changes that occur in a woman's body from the start of one period to the start of the next. Four main hormones regulate this sequence, dividing the cycle into three phases.

Hormonal fluctuations influence numerous physiological systems, and their effects during exercise may have implications for performance. Although several studies have observed performance variation between menstrual phases, others report no effects. At present, the literature lacks consensus, with conflicting results across studies. Due to methodological challenges and constraints, many studies are not sufficiently reliable to be conclusive.

The first phase of the present study aims to conduct a well-structured investigation with minimal confounding factors, employing repeated testing at precise phases of the menstrual cycle. These initial results will also serve as a control condition for the second phase, which focuses on the effects of hormonal contraception on exercise performance.

One method of regulating the hormonal cycle is hormonal contraception, the most common being the pill. This altered hormonal environment differs significantly from that of eumenorrheic women and may impact exercise performance due to changes in ovarian hormone-mediated physiological processes. Studies on oral contraceptive pill (OCP) use and exercise are typically of moderate to low quality. OCP use may result in slightly diminished exercise performance on average compared to naturally menstruating women.

To gain a comprehensive understanding of the effects of the hormonal cycle and hormonal contraception on sports performance, the present study will incorporate multiple test protocols. Three validated approaches will be used: symptom tracking, daily urinary hormone measurement throughout the tested cycle, and blood hormone analysis on each test day. Based on these data, testing will be scheduled during the following three menstrual phases: menstruation, late follicular phase (FP), and luteal phase (LP).

The study will include 60 healthy women: 30 taking a monophasic hormonal pill and 30 not using any form of hormonal contraception. Participants will be matched by age, body mass index (BMI), and activity level. Eligibility criteria include being non-smokers, non-obese, drug-free, and free of any relevant pathologies. Informed consent will be obtained from all participants. The protocol, approved by an ethical review board, ensures participant privacy and data confidentiality. All procedures and potential risks will be clearly communicated, including those associated with physical exertion and blood sampling. Health will be closely monitored throughout participation. The investigators possess extensive experience in conducting similar studies and are trained to ensure participant safety.

Initial procedures will include resting assessments: blood sampling for hormone concentrations, inflammatory markers, and metabolomics, as well as a clinical examination. In a supine position, HRV will be measured under two conditions (controlled and free ventilation) with continuous blood pressure monitoring at the finger (Finapres), ergospirometry, and continuous ECG. These assessments will provide insight into metabolism and ventilation at rest, as well as baroreflex sensitivity and HRV.

Participants will also undergo a metaboreflex test involving dynamic contraction of the forearm flexors followed by three minutes of ischemia. Blood pressure will be monitored continuously at the opposite finger (Finapres), with simultaneous ergospirometry and ECG to assess ventilatory and baroreflex responses.

Following resting and metaboreflex testing, participants will undergo a complete echocardiographic examination at rest, followed by an exercise stress echocardiography (semi-supine left tilt position) and resting lung diffusion capacity measurements. Continuous blood pressure monitoring (Finapres) will be conducted during the cardiopulmonary exercise test (CPET). Upon reaching VO₂max, participants will rest for five minutes with HRV measurement and undergo a final blood draw to assess inflammatory and metabolic markers.

Following physiological testing, participants will complete questionnaires on daily activity, nutrition, sleep, symptoms and pain, menstrual cycle patterns, well-being, and mood. On the following day, a Wingate test will be conducted.

All tests will be repeated during the same three menstrual phases (menstruation, FP, and LP), at the same time of day and under standardized nutrition and sleep conditions.

This research addresses critical factors influencing cardiovascular health. Hormonal fluctuations-particularly those associated with the menstrual cycle-have been linked to variations in blood pressure, heart rate, and vascular responsiveness. Understanding these physiological changes is vital, as they may contribute to conditions such as hypertension, atherosclerosis, and cardiac arrhythmias. It is hypothesized that both natural hormonal cycles and hormonal contraception exert subtle but meaningful effects on the cardiovascular system.

Keywords
hormonal cycle, hormonal contraception, aerobic performance, stress echocardiography, cardiovascular system, sport performance, HRV, metaboreflex, baroreflex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07779447
Study groupRoleWhat they receive
no hormonal contraceptionWomen with spontaneous regular natural cycles
under contraception - monophasic pillWomen taking monophasic contraceptive pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Oxygen Uptake (VO₂max) Assessed by Cardiopulmonary Exercise Testing

    Aerobic capacity will be assessed by maximal oxygen uptake (VO₂max) obtained during an incremental cardiopulmonary exercise test (CPET). VO₂max values will be compared across menstrual cycle phases and between naturally cycling women and women using hormonal contraception.

    Measured: From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).

Secondary outcomes (6)
  1. Right ventricular-pulmonary artery coupling across menstrual cycle phases and hormonal contraception assessed by echocardiography

    Right ventricular-pulmonary artery (RV-PA) coupling will be assessed using echocardiographic measurements obtained at rest and during exercise in naturally cycling women and women using hormonal contraception. RV-PA coupling indices will be compared across predefined menstrual cycle phases and contraceptive conditions to evaluate the influence of endogenous and exogenous sex hormones on cardiovascular adaptation.

    Measured: From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).

  2. Resting Energy Expenditure Assessed by Indirect Calorimetry

    Resting metabolic rate will be assessed by resting energy expenditure measured by indirect calorimetry under standardized resting conditions. Measurements will be compared across menstrual cycle phases and contraceptive conditions.

    Measured: From enrollment to completion of study assessments (approximately 3 months).

  3. Spontaneous cardiac sensitivity at rest

    Spontaneous cardiac baroreflex sensitivity (BRS) will be assessed at rest using spontaneous sequence analysis of continuous beat-to-beat blood pressure and electrocardiographic recordings. BRS will be expressed as the slope of the relationship between changes in systolic blood pressure and corresponding changes in the RR interval, in milliseconds per millimeter of mercury (ms/mmHg). Values will be compared across menstrual cycle phases and contraceptive conditions.

    Measured: From enrollment to completion of study assessments (approximately 3 months).

  4. Cardiac baroreflex sensitivity during dynamic exercise

    Cardiac baroreflex sensitivity (BRS) will be assessed during dynamic exercise (handgrip) using spontaneous sequence analysis of continuous beat-to-beat blood pressure and electrocardiographic recordings. BRS will be expressed as the slope of the relationship between changes in systolic blood pressure and corresponding changes in the RR interval, in milliseconds per millimeter of mercury (ms/mmHg). Values will be compared across menstrual cycle phases and contraceptive conditions.

    Measured: From enrollment to completion of study assessments (approximately 3 months).

  5. Resting heart rate variability assessed by electrocardiography

    Cardiac autonomic modulation at rest will be assessed using heart rate variability (HRV) parameters derived from electrocardiographic recordings. Time-domain and frequency-domain HRV indices will be compared across menstrual cycle phases and contraceptive conditions.

    Measured: From enrollment to completion of study assessments (approximately 3 months).

  6. Anaerobic power assessed by the Wingate anaerobic test

    Anaerobic performance will be assessed by mean/peak anaerobic power measured during a standardized Wingate Anaerobic Test. Performance outcomes will be compared across menstrual cycle phases and contraceptive conditions.

    Measured: From enrollment to completion of study assessments (approximately 3 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start1 Feb 2024
  3. Primary completion31 Mar 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779447
Sponsor's protocol ID
ciccle2425
Acronym
CICCLE
Status last verified
Aug 2026
First submitted
11 Jun 2025
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not necessary in our study

Questions about this trial

What is this clinical trial studying?

An observational study of Women Under Hormonal Contraception (Pill) or Without Hormonal Contraception, run by Université Libre de Bruxelles at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Oxygen Uptake (VO₂max) Assessed by Cardiopulmonary Exercise Testing (time frame: From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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