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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00055302
Eligibility Criteria:
Inclusion Criteria:
* informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
* females less than or equal to 10 years of age
* diagnosed with McCune-Albright Syndrome
* have progressive precocious puberty
Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:
* any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
* concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
* liver function tests at screening visit (AST, ALT) \> or = 3x the upper limit of the reference range for age
* known hypersensitivity to any component of study medication
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
10 Years
Study:
NCT00055302
Study Brief:
Protocol Section:
NCT00055302