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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT03450135
Eligibility Criteria:
Inclusion Criteria:
* Female, 11 to 14 years of age
* Meet Tanner developmental stage criteria (as indicated by self-report and pictorial scales of breast and pubic hair development) for pubertal stages 3 or 4
* Must be undergoing a healthy pubertal transition, pre-or-post menarche (within 15 months of menarche, with cycle irregularity)
* Girls must be able to read at a 4th-grade reading level
Exclusion Criteria:
* Current suicidal intent (based off Columbia-Suicide Severity rating scale)
* A history or current diagnosis of bipolar disorder or psychosis
* Currently on any prescription medications
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
11 Years
Maximum Age:
14 Years
Study:
NCT03450135
Study Brief:
Protocol Section:
NCT03450135