Last updated: December 5, 2023
Sponsor: Western University, Canada
Overall Status: Active - Recruiting
Phase
N/A
Condition
Birth Control
Menstruation
Treatment
Exercise and blood draw
Clinical Study ID
NCT05683119
120869
Ages 18-40 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 someathletes 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 anymedication known to affect any of the outcome measures. Examples include diagnosedhyperandrogenism from polycystic ovary syndrome, congenital adrenal hyperplasia, orother differences in sexual development.
- Cannot smoke
- Considered to be physically active. Participants training status will be classifiedusing the criteria outlined by McKay et al. (In press). For this study, participantsmust be Tier 2 athletes or above (Table 1). In addition, participants will beconsidered on the basis of relative maximal oxygen consumption (Decroix et al., 2016);needing to be Performance Level 2 or above (Table 2). Participants must providedetails 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 berecruited based on their endogenous hormonal profile (i.e., eumenorrheic or OCP users)and these profiles (including inclusion/exclusion criteria) are described below indetail. Group Specific Inclusion Criteria: Group 1. Eumenorrheic [EUM]
- Must have menstrual cycle lengths ≥ 21 days and ≤ 35 days resulting in 9 or moreconsecutive 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 forpermitted brands)
- Must demonstrate the correct hormonal profile as defined in Table 5
Exclusion
Exclusion Criteria:
-Cannot speak, read and understand English
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Exercise and blood draw
Phase:
Study Start date:
September 20, 2023
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Fowler Kennedy Sport Medicine Clinic
London, Ontario N6A 3K7
CanadaActive - Recruiting

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