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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT02723305
Eligibility Criteria:
Inclusion Criteria:
* Male, 47,XXY karyotype (non-mosaic)
* Age 12-17 years
* Tanner stage 3-5 pubic hair
* T naïve group only: No exogenous androgen exposure within the past 5 years
* T exposed group only: currently on topical testosterone, with duration of treatment between 1-2 years.
Exclusion Criteria:
* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* MRI incompatible metal
* Diagnosis of type 1 or type 2 diabetes
* Hypertension greater than 140/90 mm/Hg at rest (would make exercise studies unsafe)
* Weight \> 300 lbs (limit for DEXA)
* Testosterone treatment for \<1 year or \>2 years
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02723305
Study Brief:
Protocol Section:
NCT02723305