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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT01062568
Eligibility Criteria:
Inclusion Criteria:
* Normal CBC (Hemoglobin must be at least 11mg/dl)
* Normal renal and liver function tests (AST\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
* direct bili \<0.2 mg/dL;
* total bili \<1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)
Exclusion Criteria:
* Pregnancy
* On oral contraceptives
* On insulin lowering drugs
* On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
* On medications that will influence androgen metabolism or clearance
* On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
* Subjects with morning cortisol\<5 ug/dL will be excluded and asked to see their primary care physician.
* Subjects with 17-OHP\>250 ng/dL) will be excluded and asked to see their primary care physician.
* Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT01062568
Study Brief:
Protocol Section:
NCT01062568