Investigating how menstrual cycle and contraceptive use affect exercise performance in female athletes
The Effect of Menstrual Cycle and Oral Contraceptive Pill Phase on Aspects of Exercise Physiology and Athletic Performance in Female Athletes
This study tests how the menstrual cycle and birth control pills affect exercise performance in female athletes to help improve their training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05683119 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of the menstrual cycle and oral contraceptive pill phases on exercise physiology and athletic performance in female athletes. It focuses on how fluctuations in hormones like oestradiol and progesterone influence muscle strength, oxygen uptake, and overall athletic performance. By conducting blood tests and exercise assessments, the research aims to provide insights that could help optimize training schedules for active women. The study addresses a gap in existing research, which has been inconsistent and lacks high-quality data on this topic.
Who should consider this trial
Good fit: Ideal candidates are cisgender women aged 18-40 who are physically active and classified as Tier 2 athletes or above.
Not a fit: Patients with medical conditions affecting hormonal levels or those who are not physically active may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored training recommendations for female athletes based on their hormonal profiles.
How similar studies have performed: While some emerging research has suggested links between hormonal phases and athletic performance, high-quality studies specifically addressing this relationship are limited and often contradictory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cis gender women * 18-40 years of age * Body mass index ≥ 19.5 and ≤ 25 kg∙-2; an exception can be made in the case of some athletes where they have a higher BMI, but are considered more lean/muscular than fat. * Must be defined as healthy, i.e., not having any medical condition or taking any medication known to affect any of the outcome measures. Examples include diagnosed hyperandrogenism from polycystic ovary syndrome, congenital adrenal hyperplasia, or other differences in sexual development. * Cannot smoke * Considered to be physically active. Participants training status will be classified using the criteria outlined by McKay et al. (In press). For this study, participants must be Tier 2 athletes or above (Table 1). In addition, participants will be considered on the basis of relative maximal oxygen consumption (Decroix et al., 2016); needing to be Performance Level 2 or above (Table 2). Participants must provide details on gravidity and parity and must not be in the postpartum period (i.e., within 12 months of childbirth), currently breastfeeding, or pregnant. Participants will be recruited based on their endogenous hormonal profile (i.e., eumenorrheic or OCP users) and these profiles (including inclusion/exclusion criteria) are described below in detail. Group Specific Inclusion Criteria: Group 1. Eumenorrheic \[EUM\] * Must have menstrual cycle lengths ≥ 21 days and ≤ 35 days resulting in 9 or more consecutive periods per year * Must provide evidence of a luteinising hormone (LH) surge * Must demonstrate the required hormonal profile as defined in Table 3 * Cannot have used any type of hormonal contraceptives (HC) for a minimum of 3 months, but ideally 6 months, prior to enrolment Group 2. Oral contraceptive pill \[OCP\] users * Must have been taking their OCP ≥ 3 months prior to recruitment * Must be taking a combined, monophasic, second generation OCP (see Table 4 for permitted brands) * Must demonstrate the correct hormonal profile as defined in Table 5 Exclusion Criteria: -Cannot speak, read and understand English
Where this trial is running
London, Ontario
- Fowler Kennedy Sport Medicine Clinic — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jane Thornton — Schulich-Family Medicine
- Study coordinator: Ashley Ambrose
- Email: ashley.ambrose@lhsc.on.ca
- Phone: 519-661-2111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.