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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT00564850
Eligibility Criteria:
Inclusion Criteria in the screening phase:
* Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys.
* Weight ≥ 20 kg.
Inclusion Criteria in the treatment phase:
* Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys.
* Age at evaluation less than 9 years for girls and 10 years for boys.
* A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).
* Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) \> 1 year.
* Testosterone level ≥ 0.5 ng/ml in boys.
Exclusion Criteria:
* Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.
* Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.
* Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).
* The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00564850
Study Brief:
Protocol Section:
NCT00564850