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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT01438034
Eligibility Criteria:
Inclusion Criteria:
Adolescent Boys
* ages 13.5-17 years
* testicular volume \<4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer
* first morning (before 9AM) LH \<2 mIU/mL and testosterone \<50 ng/dL
Adolescent Girls
* ages 12-17 years
* Tanner stage I OR II breast development with no change in the past 6 months
* first morning (before 9AM) LH \<2 mIU/mL and estradiol \<20 pg/ml
All Subjects:
* bone age less than chronological age
* weight ≥ 28 kg
* body mass index \>10th percentile and \<+3 SDS for bone age
* blood pressure \>5th percentile and \<95th percentile for bone age and height
* white blood cell counts, platelet counts, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age
* erythrocyte sedimentation rate \<2X the upper limit of the reference range for age
* hemoglobin within reference range for girls of the same chronological age
* blood urea nitrogen (BUN), creatinine, prolactin not elevated
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2X the upper limit of the reference range
* Insulin-like growth factor 1 (IGF-1) within reference range for bone age
Exclusion Criteria:
All Subjects:
* history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))
* history of an allergic drug reaction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT01438034
Study Brief:
Protocol Section:
NCT01438034