The Effect of Menstrual Cycle and Oral Contraceptive Pill Phase on Aspects of Exercise Physiology
Launched by WESTERN UNIVERSITY, CANADA · Jan 5, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how the menstrual cycle and the use of oral contraceptive pills affect exercise and athletic performance in women. Researchers want to understand how changes in hormones, specifically oestradiol and progesterone, during different phases of the menstrual cycle and when taking birth control pills, influence things like muscle strength and how well athletes can perform. By learning this, the study aims to find out if certain hormone levels can impact how women athletes train and compete.
To participate in the study, women must be between 18 and 40 years old, be healthy and physically active, and have a body mass index (BMI) within a certain range. Participants should either have regular menstrual cycles or have been using a specific type of oral contraceptive for at least three months. It's important that participants are not pregnant, breastfeeding, or within one year of giving birth. They will be asked to provide some health and exercise history, and all communication will be in English. If you’re eligible and choose to join, you’ll help researchers uncover valuable information about how female athletes can optimize their training and performance based on their hormonal profiles.
Gender
FEMALE
Eligibility 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
About Western University, Canada
Western University, located in Canada, is a leading research institution committed to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its faculty and research teams to conduct high-quality studies that address pressing medical challenges. Western University is dedicated to fostering a culture of ethical research practices, ensuring participant safety, and generating impactful findings that contribute to evidence-based medicine and improve patient outcomes. Through its robust infrastructure and commitment to excellence, Western University plays a vital role in the field of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, Ontario, Canada
Patients applied
Trial Officials
Jane Thornton
Principal Investigator
Schulich-Family Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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