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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT00001202
Eligibility Criteria:
INCLUSION CRITERIA:
Patients with familial male precocious puberty will be admitted to the Clinical Center.
In order to be eligible for the study, the following criteria will be met:
Boys 10 years of age or less.
Tanner II to IV pubertal development.
Unfused epiphyses by bone films.
Evidence that precocious puberty is not secondary to another recognized cause of pseudopuberty:
1. We will exclude congenital adrenal hyperplasia, and document pretreatment androgen levels, by a 1-hour ACTH test, which will include measurement of 11-deoxycortisol and 17-OH-progesterone at 0 and 60 minutes.
2. We will exclude tumor of adrenal or testes by physical exam, ultrasound, and measurement of adrenal androgens (DHA, DHAS, androstenedione).
Elevated testosterone levels measured at 10 am, 2pm, 10 pm and 2 am over a 24 hour period.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00001202
Study Brief:
Protocol Section:
NCT00001202