The Effect of Menstrual Cycle and Oral Contraceptive Pill Phase on Aspects of Exercise Physiology

NCT ID: NCT05683119

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2024-12-31

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.

Detailed Description

The menstrual cycle is the body's way of preparing for pregnancy. A "normal" or "healthy" cycle lasts an average of 21-35 days, which starts on the first day of bleeding. Throughout each cycle, levels of the hormones oestrogen and progesterone vary. The oral contraceptive pill is designed to prevent pregnancy; one way it does this is by lowering the levels of oestrogen and progesterone. The main purpose of oestrogen and progesterone is for reproduction. These hormones have also been shown to affect other bodily functions. The effects of oestrogen and progesterone on a woman's capacity to undertake exercise is an important factor for active women to consider to optimise training schedules and athletic performances. Emerging research has suggested that menstrual cycle phase or oral contraceptive use is associated with changes in sport and exercise performance. However, research on this topic is lacking (both in quality and quantity), and currently is quite contradictory. Much more high-quality research is required to explore the impact of both natural and supplemented oestrogen and progesterone on exercise-related outcomes to give convincing advice to active women. This research must follow strict procedural guidelines and include accurate hormonal measurement (through blood samples) to increase its usefulness to exercising women. Such research is needed to establish a cause-and-effect relationship for any differences in exercise physiology and athletic performance between the different phases of the menstrual cycle, between phases of oral contraceptive pill taking and not-taking, and between women using or not-using oral contraceptives.

Conditions

Menstrual Cycle; Oral Contraceptives

Keywords

Athletic performance; Exercise physiology; Female; Athlete

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise and blood draw

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Exercise and blood draw

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane Thornton

Role: PRINCIPAL_INVESTIGATOR

Schulich-Family Medicine

Locations

Fowler Kennedy Sport Medicine Clinic

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ashley Ambrose

Role: CONTACT

Phone: 519-661-2111

Email: ashley.ambrose@lhsc.on.ca

Facility Contacts

Kristen Reilly

Role: primary

Other Identifiers

120869

Identifier Type: -

Identifier Source: org_study_id