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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04806451
Eligibility Criteria:
Inclusion Criteria:
* Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit.
* Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency.
* Be on a stable steroid regimen.
* Have elevated androgen levels.
* Participants of childbearing potential must be abstinent or agree to use appropriate birth control during the study.
Exclusion Criteria:
* Have a diagnosis of any of the other forms of classic CAH.
* Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
* Have a clinically significant unstable medical condition or chronic disease other than CAH.
* Have a history of cancer unless considered to be cured.
* Have a known history of clinically significant arrhythmia or abnormalities on electrocardiogram (ECG).
* Have a known hypersensitivity to any corticotropin-releasing hormone antagonist.
* Have received an investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
* Have current substance dependence or substance (drug) or alcohol abuse.
* Have had a significant blood loss or donated blood or blood products within 8 weeks prior to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT04806451
Study Brief:
Protocol Section:
NCT04806451