Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT06832293
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
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT06832293
Study Brief:
Protocol Section:
NCT06832293