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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05497167
Eligibility Criteria:
Inclusion Criteria:
1. Minors from 5 to 17 years of age
2. Those with the capacity to eventually menstruate but who have not yet had a menstrual period
3. Those with an Intellectual and Developmental Disability (IDD), defined here using DSM diagnostic labels: autism spectrum disorder, Global Developmental Delay, Unspecified Neurodevelopmental Disorder (which includes Down Syndrome and fragile-X)
Exclusion Criteria:
1. Those that do not meet any of the aforementioned criteria
2. Minors who are:
i) married, widowed, divorced; or ii) the parent of a child; or iii) a member of any of the armed forces; or iv) pregnant or believes herself to be pregnant; or v) living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs
3. Wards of the state and/or children at risk of becoming wards of the state
4. Non-English speakers
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT05497167
Study Brief:
Protocol Section:
NCT05497167