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:
NCT03897504
Eligibility Criteria:
Inclusion criteria:
* Females (46, XX genotype identified by karyotype
* Age: infants and children from 18 months old age to 14 years
* Virilized external genitalia.
* Persistent urogenital sinus
* Congenital adrenal hyperplasia.
* Controlled by glucocorticoid and mineralocorticoid replacement therapy and clinically and hormonally judged fit for surgical interventions.
* Voluntarily provided informed written consent of the parents for the planned procedure and possible risks.
* Informed written approval of the parents of the included children to use clinical data collected in a research program.
Exclusion Criteria:
* Male disorders of sexual development (46 XY)
* Debatable sex of rearing; Mixed gonadal dysgenesis, Ovotesticular disorders of sexual development and partial androgen insensitivity syndrome.
* Inadequate compliance with corticosteroid therapy, rendering surgery or interventions clinically hazardous or unsuitable.
* Inadequately controlled hormonal assay: elevated androgens.
* Patients who did any corrective surgery before.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Months
Maximum Age:
14 Years
Study:
NCT03897504
Study Brief:
Protocol Section:
NCT03897504