Understanding how menstrual cycles affect MS symptoms
Measuring MS Symptoms in Relation to Menstrual Cycles: Exploring How MS Symptoms May be Affected at Different Times During a Menstrual Cycle in Females Living With Multiple Sclerosis
This study looks at how different phases of the menstrual cycle might affect MS symptoms like fatigue, pain, and mobility in people who menstruate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT06832293 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between menstrual cycle phases and the symptoms of Multiple Sclerosis (MS) in individuals who menstruate. Participants will track their menstrual cycles and MS symptoms using the My Normative app, completing symptom check-ins at five points during their cycle over six months. The study seeks to determine if fatigue and other symptoms like cognition, pain, and mobility fluctuate during different phases of the menstrual cycle. The findings may provide insights into symptom management for those living with MS.
Who should consider this trial
Good fit: Ideal candidates are females aged 16 or older diagnosed with MS who experience regular menstrual cycles.
Not a fit: Patients who are male, intersex, or have other CNS inflammatory disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of MS symptoms in relation to menstrual cycles.
How similar studies have performed: While there is limited research specifically on this topic, understanding hormonal influences on MS symptoms has shown promise in related studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female participants diagnosed with MS based on the 2024 McDonald Diagnostic criteria (biologically sex-based, any gender as long as not on hormonal gender-enhancing therapy) * Aged 16 or older * Experiencing menstruation with cycles ranging from 21 to 35 days * Have entered menarche, still experiencing menstrual cycles, and have not yet entered menopause * May be using hormonal contraceptive methods (e.g., oral contraceptives or hormonal IUDs) * Able to speak English * Willing to provide informed consent (mature minors will be assessed by their physician for consent eligibility) * Able to complete questionnaires and operate the app Exclusion Criteria: * Diagnosed with CNS inflammation disorders other than MS, such as: NMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease) * Male or intersex individuals, given the inclusion criteria of requiring a uterus * Females under 15 years of age * Females who have not started menstruation * Females who have stopped menstruation due to menopause or hysterectomy * Pregnant or postpartum individuals within one year of delivery, * Individuals currently breastfeeding * Unable to provide informed consent, or not deemed a mature minor * Unable to complete questionnaires and operate the app
Where this trial is running
Calgary, Alberta and 1 other locations
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Penny Smyth, MD — University of Alberta
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.