My MS and My Menstrual Cycle (NCT06832293) | Clinical Trial Compass
SuspendedNot Applicable
My MS and My Menstrual Cycle
Stopped: Logistical reasons
Canada300 participantsStarted 2025-02-19
Plain-language summary
The goal of this observational study is to understand how MS symptoms change during different phases of the menstrual cycle in individuals who menstruate living with MS (Multiple Sclerosis).
The main questions it aims to answer are:
1. Does fatigue get worse during certain phases of the menstrual cycle?
2. How do symptoms like thinking skills, pain, and mobility change throughout the cycle?
Participants will:
* Use the My Normative app to track their menstrual cycle and MS symptoms.
* Complete symptom check-ins at five points during their cycle for six months.
* Answer questions about fatigue, thinking skills, mood, sleep, and other MS symptoms at the start and end of the study.
These findings may help researchers better understand MS symptom patterns and improve symptom management.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months
Timeframe: The MFIS-5 is assessed at baseline (study entry), five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months, and study completion (on average, 6 months later)