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Menstrual Cycle and Birth Control Pills for Exercise Physiology

N/A

Recruiting

Led By Jane Thornton

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cis gender women

18-40 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visits 2-9 (eum group) and visits 3, 5, 7-10 (ocp group). through study completion, an average of 5 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how hormones during the menstrual cycle and OC pill use affect exercise physiology and athletic performance in female athletes.

Who is the study for?

This trial is for cisgender women aged 18-40, with a BMI between 19.5 and 25 (athletes may qualify if more muscular), who are healthy, not on medications affecting the study outcomes, physically active as defined by specific athletic criteria, and not pregnant or postpartum within the last year. Smokers are excluded.

What is being tested?

The study examines how menstrual cycles and phases of oral contraceptive pill use affect exercise physiology and athletic performance in female athletes. It will measure muscle strength, oxygen uptake, and other performance indicators against hormonal changes.

What are the potential side effects?

Since this trial involves exercise and blood draws rather than medication or invasive procedures, side effects might include typical exercise-related discomforts such as muscle soreness or fatigue, as well as minor bruising or pain from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a cisgender woman.

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I am between 18 and 40 years old.

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I am healthy and not on medication that affects the study's measures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visits 2-9 (eum group) and visits 3, 5, 7-10 (ocp group). through study completion, an average of 5 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visits 2-9 (eum group) and visits 3, 5, 7-10 (ocp group). through study completion, an average of 5 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 2-9 (eum group) and visits 3, 5, 7-10 (ocp group). through study completion, an average of 5 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Sample

Countermovement (power) jump

Cycling Protocol

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: OCP GroupExperimental Treatment1 Intervention

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 II: EUM GroupExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met