My MS and My Menstrual Cycle

NCT06832293 | Suspended

• 1 other identifier: Pro00140591
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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:

• 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.

Conditions

Multiple Sclerosis; Menstrual Cycle

Keywords

Multiple Sclerosis; Menstrual Cycle; MS Symptoms; Fatigue; Cognition

Outcome Measures

Primary Outcomes (1)

• Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months

  The Modified Fatigue Impact Scale-5 (MFIS-5) measures the impact of fatigue on cognitive, physical, and psychosocial functions. It uses a 5-point Likert scale for each item, with the following scoring range for each of the 5 items: 0: Never 1. Rarely 2. Sometimes 3. Often 4. Almost Always The total score is the sum of the five items, with a range from 0 to 20. A higher score indicates a greater impact of fatigue on daily functioning. In terms of interpreting the score: A score of 0 would indicate no impact from fatigue. A score of 20 would indicate the maximum possible impact of fatigue on daily functioning. This scale is used to assess fatigue severity in individuals with multiple sclerosis (MS) and other conditions where fatigue is a prominent symptom. A higher score reflects a greater degree of fatigue-related disruption to cognitive, physical, and social tasks.

  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)

Secondary Outcomes (6)

• Qualitative Self-Reported Differences in Self-Perceived Cognitive Function Across Menstrual Cycle Phases

  The Cognition Likert Scale is assessed at baseline (study entry) and at five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months

• Qualitative Self-Reported Differences in Hospital Anxiety and Depression Scale (HADS) Scores

  The HADS is assessed at baseline (study entry) and study completion (on average, 6 months later)

• Qualitative Self-Reported Difference in Mini-COPE Scores Across Menstrual Cycle Phases

  The Mini-COPE 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)

• Qualitative Self-Reported Difference in MFC (Motivation for Cognition) Scores Across Menstrual Cycle Phases

  The MFC 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)

• Qualitative Self-Reported Difference in SymptoMScreen Scores Across Menstrual Cycle Phases

  The SymptoMScreen 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)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be female individuals with confirmed diagnosis of Multiple Sclerosis (MS) who experience a regular menstrual cycle.

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with CNS inflammation disorders other than MS, such as:
• NMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease)
• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Penny Smyth, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 18, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)