Recruiting

Observational Study

Sponsor:

Western University, Canada

Code:

NCT05683119

Conditions

Menstrual Cycle

Oral Contraceptives

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Exercise and blood draw

Study Details

Brief summary:

This study will investigate the effect of menstrual cycle (MC) and oral contraceptive pill phase on aspects of exercise physiology and athletic performance in female athletes. Specifically, this study intends to investigate the effects of circulating fluctuations in oestradiol and progesterone, experienced during the menstrual cycle and oral contraceptive pill use, on aspects of exercise physiology and athletic performance in female athletes. This research will help researchers determine if a particular hormonal profile affects physiological functioning such as muscle strength, maximum oxygen uptake and athletic performance in female athletes.

Conditions

Menstrual Cycle

Oral Contraceptives

Study ID

NCT05683119

Start date

Sep 20, 2023

Status verified date

Dec, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: EUM Group

Participants must: have menstrual cycle lengths ≥ 21 days and ≤ 35 days resulting in 9 or more consecutive periods per year; provide evidence of a luteinising hormone (LH) surge; demonstrate the required hormonal profile as defined below; and have not used any type of hormonal contraceptives (HC) for a minimum of 3 months, but ideally 6 months, prior to enrolment.

Phase 1- Indicated by the onset of bleeding until day 5 Oestrogen and progesterone levels are low

Phase 2- Oestrogen higher than during phase 1 and 3 Progesterone higher than during phase 1, but lower than 6.36 nmol·L-1 Must be followed by a positive luteinising hormone surge

Phase 3- +7 days after ovulation has been confirmed Oestrogen higher than phase 1, but lower than phase 2 Progesterone >16 nmol·L-1

experimental: OCP Group

Participants must: have been taking their OCP ≥ 3 months prior to recruitment; be taking a combined, monophasic, second generation OCP; and demonstrate the correct hormonal profile as defined below.

Pill-taking phase- Indicated by the 21 consecutive pill-taking days Oestrogen and progesterone levels are low; ≤ phase 1 of the menstrual cycle

Pill-free phase- Indicated by the 7 consecutive pill-free days Oestrogen and progesterone levels may begin to rise in comparison with the pill-taking phase

Interventions

Exercise and blood draw

This project intends to investigate the effects of circulating fluctuations in oestradiol and progesterone, experienced during the menstrual cycle \[MC\] and oral contraceptive pill \[OCP\] use, on aspects of exercise physiology and athletic performance in female athletes. This research aims to determine if a particular hormonal profile affects physiological functioning (e.g., muscle strength, maximum oxygen uptake) and/or athletic performance in female athletes. The intervention will include a stretching regimen, balance test, push-ups, agility test, handgrip muscle test, vertical jump, flexibility test, cycling protocol, blood sample and height/ weight measurements.

Primary outcome measure

  • Blood Sample [ Time Frame: Every visit (9-10 blood draws depending on the group). Through study completion, an average of 5 months. ]
  • Cycling Protocol [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]
  • Height [ Time Frame: First visit only- Month 1 ]
  • Weight [ Time Frame: Through study completion, an average of 5 months. ]
  • Stork Balance Stand Test [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]
  • Muscular Endurance: Push-ups [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]
  • Illinois Agility Test [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]
  • Muscular Strength: Handgrip [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]
  • Countermovement (power) jump [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]
  • Sit and Reach Flexibility Test [ Time Frame: Visits 2-9 (EUM Group) and Visits 3, 5, 7-10 (OCP Group). Through study completion, an average of 5 months. ]

Central Contacts and Locations

Central contacts

Ashley Ambrose

519-661-2111ashley.ambrose@lhsc.on.ca

Locations

Fowler Kennedy Sport Medicine Clinic

Recruiting

London, Ontario, Canada, N6A 3K7

Contacts

Kristen Reilly

519-661-2111kreill2@uwo.ca

More Information

Sponsor

Western University, Canada

Last update posted

Dec 12, 2023

Last verified

Dec, 2023

Keywords

  • Athletic performance
  • Exercise physiology
  • Female
  • Athlete

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2023-12-12.