My MS and My Menstrual Cycle

NCT ID: NCT06832293

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-19
• Study Completion Date: 2027-01-31

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:

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.

Conditions

Multiple Sclerosis; Menstrual Cycle

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• 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

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny Smyth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Sarah Morrow, MD

Role: primary

calgarymsresearch@ucalgary.ca

403-944-4187

Penny Smyth, MD

Role: primary

smyth@ualberta.ca

780-248-1775

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00140591

Identifier Type: -

Identifier Source: org_study_id