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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02389803
Eligibility Criteria:
Inclusion Criteria:
* Boys aged ≥10years old
* Prepubertal - Tanner stage 1 (gonadarche) (testicular volume\<4)
* Height and weight ≤ 10th percentile for age and gender.
* Height-SDS ≥ -2.5 SDS
* BMI-SDS\>-3 SDS
* Low proportion between weight and height
* Signing inform consent forms
Exclusion Criteria:
* Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
* Any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
* Any known gastrointestinal disease including malabsorption
* Any known organic reason for growth retardation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
10 Years
Maximum Age:
15 Years
Study:
NCT02389803
Study Brief:
Protocol Section:
NCT02389803