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:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT07268404
Eligibility Criteria:
Inclusion Criteria:
* Self-reported irregular menstrual cycles, defined as one or more of the following:
* Cycle length typically \>35 days OR \<21 days
* Fewer than 9 menstrual periods in the past year
* Unpredictable cycle timing (varies by \>7 days month-to-month)
* Irregular cycles present for ≥6 months
* One or more of the following hormonal balance concerns: skin, unwanted hair growth, hair thinning, weight concerns)
* Self-reported emotional symptoms that fluctuate with menstrual cycle, including:
* Mood swings or irritability
* Feelings of stress or tension
* Low mood or feeling down
* Difficulty with emotional regulation
* Not currently using hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens.
* If taking supplements for menstrual/hormonal support: willing to discontinue for 2-week washout before baseline
* Weight stable (+ 5 pounds) for the past 2 months, not planning to start a new diet, exercise program, or medications during study
* Able to provide electronic informed consent.
* Willing to complete online surveys and at-home DBS sample collection.
* Negative home pregnancy test at baseline.
* Access to a computer or smartphone and reliable internet connection.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07268404
Study Brief:
Protocol Section:
NCT07268404