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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00870220
Eligibility Criteria:
Inclusion Criteria:
* 60 subjects will be recruited from participating Pediatric Endocrinology Clinics in the United States.
* Subjects will be 11.5-13.0 years of age and must have completed at least 6 months of GH therapy prior to the study.
* Subjects may not have had any estrogen prior to the study. All subjects must be breast stage 1 and euthyroid prior to the study
* Those on thyroid medication will continue the appropriate thyroid replacement therapy during the study.
Exclusion Criteria:
* On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
138 Months
Maximum Age:
13 Years
Study:
NCT00870220
Study Brief:
Protocol Section:
NCT00870220