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Multiple SclerosisNCT06832293

My MS and My Menstrual Cycle

An observational study of Multiple Sclerosis and Menstrual Cycle, run by University of Alberta at 2 sites in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Multiple Sclerosis, Menstrual Cycle
How many people
300 participants
Where
2 sitesCanada
Study dates
19 Feb 2025to 31 Jan 2027
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Calgary

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

Official title: 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

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:

Read more
  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.

Keywords
Multiple Sclerosis, Menstrual Cycle, MS Symptoms, Fatigue, Cognition
Medical subject headings
Multiple Sclerosis, Fatigue

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

    The Cognition Likert Scale measures self-perceived cognitive function in individuals with MS. It consists of two items rated on a 7-point Likert scale:

    1. Perceived Cognitive Function Compared to Peers (ex. 1 = Severely worse, 4 = Unchanged, 7 = Significantly better).
    2. Frequency of Cognitive Difficulties (ex. 1 = Never, 4 = Sometimes, 7 = All the time).

    Each item is interpreted independently.

    Interpreting the Score:

    A lower score on the Perceived Cognitive Function scale (e.g., 1-3) suggests greater cognitive impairment, while a higher score (e.g., 5-7) indicates better cognitive function compared to peers.

    A lower score on the Frequency of Cognitive Difficulties scale (e.g., 1-3) suggests fewer cognitive challenges, while a higher score (e.g., 5-7) indicates more frequent cognitive difficulties.

    This scale is used to assess cognitive function in individuals with MS, allowing for the identification of self-reported changes in cognition over time.

    Measured: 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

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

    The Hospital Anxiety and Depression Scale (HADS) measures symptoms of anxiety and depression in individuals with MS. It consists of 14 self-reported items, with 7 items assessing anxiety and 7 items assessing depression over the past week.

    Each item is rated on a 4-point Likert scale (0-3), with total scores ranging from 0 to 21 for anxiety and 0 to 21 for depression.

    Interpreting the Score:

    0-7: Normal (no significant symptoms) 8-10: Borderline anxiety or depression 11-21: Clinical levels of anxiety or depression Higher scores indicate greater severity of anxiety and/or depression symptoms. The HADS is widely used in clinical and research settings to assess emotional well-being in individuals with chronic conditions like MS.

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

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

    The Mini-COPE (MS-Specific Brief COPE) measures coping strategies used in response to stress. The scale assesses problem-focused coping, emotion-focused coping, and maladaptive coping. It consists of 28 self-reported items, each rated on a 4-point

    Likert scale:

    0 = I hardly ever do this

    1. = I rarely do this
    2. = I do this often
    3. = I almost always do this

    Interpreting the Score:

    • Higher scores indicate more frequent use of a specific coping strategy.
    • Individual scores provide insight into which coping mechanisms are most commonly used in response to stress.

    The Mini-COPE is widely used in MS research to understand coping behaviors and their impact on psychological well-being.

    Measured: 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)

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

    The Motivation for Cognition (MFC) Scale measures an individual's motivation to engage in cognitive tasks at a given moment. It consists of 10 self-reported items, each rated on a 7-point Likert scale:

    • 3 = Very strongly does not apply to me
    • 2 = Strongly does not apply to me
    • 1 = Somewhat does not apply to me 0 = Neutral
    • 1 = Somewhat applies to me
    • 2 = Strongly applies to me
    • 3 = Very strongly applies to me

    Interpreting the Score:

    • Higher scores indicate greater motivation for engaging in cognitive tasks.
    • Lower scores suggest reduced interest in or avoidance of cognitively demanding activities.

    The MFC Scale will be used to evaluate fluctuations in cognitive motivation over time, particularly in relation to MS symptoms and menstrual cycle phases.

    Measured: 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)

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

    The SymptoMSScreen measures the impact of MS symptoms on daily life and the accommodations individuals make due to these symptoms. The scale evaluates walking, hand function, spasticity, pain, sensory symptoms, bladder control, fatigue, vision, dizziness, cognition, depression, and anxiety. It consists of 12 self-reported items, each rated on a 7-point Likert scale:

    0 = No effect at all

    1. = Very mild limitation
    2. = Mild limitation
    3. = Moderate limitation
    4. = Severe limitation
    5. = Very severe limitation
    6. = Total limitation

    Interpreting the Score:

    • Higher scores indicate greater MS-related disability and symptom burden.

    The SymptoMSScreen is used in MS research to assess symptom severity and it's impact on daily functioning. It's use will help track symptom progression and variability across menstrual cycle phases.

    Measured: 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)

  6. Qualitative Self-Reported MSNQ (Multiple Sclerosis Neuropsychological Screening Questionnaire) Scores

    The Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ) assesses cognitive and emotional difficulties in individuals with MS. The scale assesses attention, memory, problem-solving, impulse control, and emotional regulation. It consists of 15 self-reported items, each rated on a 5-point Likert scale based on frequency and severity over the past three months:

    0 = Never, does not occur

    1. = Very rarely, no problem
    2. = Occasionally, seldom a problem
    3. = Quite often, interferes with life
    4. = Very often, very disruptive

    Interpreting the Score:

    • Higher scores indicate greater cognitive and emotional impairment related to MS.

    The MSNQ is commonly used in MS research to identify cognitive difficulties and their impact on daily life. The use of MSNQ will help track cognitive fluctuations across menstrual cycle phases.

    Measured: The MSNQ will be assessed at baseline (study entry) and study completion (on average, 6 months later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start19 Feb 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Why it stopped: Logistical reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832293
Sponsor's protocol ID
Pro00140591
Status last verified
Apr 2026
First submitted
6 Feb 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Menstrual Cycle, run by University of Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06832293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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My MS and My Menstrual Cycle (NCT06832293) | AzTrials