My MS and My Menstrual Cycle

University of Alberta

Status: Enrolling

Conditions: Multiple Sclerosis; Menstrual Cycle

Study type: Observational

Funder types: Other

Identifiers

NCT06832293

Pro00140591

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design