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EUM Group for Menstruation

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood Sample

Countermovement (power) jump

Cycling Protocol

+7 more

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

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor

239 Previous Clinical Trials

56,901 Total Patients Enrolled

Jane ThorntonPrincipal InvestigatorSchulich-Family Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there age restrictions for enrollment in this experiment?

"The age restriction for this research is between 18 and 40 years old."

Answered by AI

Are there current opportunities for participants in this investigation?

"According to clinicaltrials.gov, the trial is still open and actively searching for volunteers. This research was initially posted on September 20th of 2023 with its most recent update occurring on December 5th of that same year."

Answered by AI

How many subjects are being monitored in this research project?

"Affirmative. As per the information found on clinicaltrials.gov, this medical study is currently seeking patients to enroll in it; first posted on September 20th of 2023 and most recently updated on December 5th of that same year. The research requires a total of 20 participants from one particular site."

Answered by AI

How can I join the research initiative?

"The trial is accepting 20 cisgender women between 18 and 40 years old who possess a healthy BMI that falls between 19.5 to 25 kg/m2, excluding those with higher BMIs due to being athletes (an exception can be made in this case). Furthermore, these participants must not smoke or take any medications known to affect the outcome measures, as well as meet certain physical activity criteria based on their training status and relative maximal oxygen consumption. Also, gravidity and parity information will need to be provided by each candidate; additionally, they cannot currently be pregnant nor within twelve months of childbirth or breastfeeding. All candidates must also have endogenous hormonal"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The Effect of Menstrual Cycle and Oral Contraceptive Pill Phase on Aspects of Exercise Physiology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05683119.