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 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT01427595
Eligibility Criteria:
Inclusion Criteria:
* Girls ages 10 to 17
* Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
* Creatinine clearance \> 90 ml/min as calculated by the Cockcroft-Gault equation
* Hemoglobin \> 12 mg/dL or Hematocrit \> 36%
* Normal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
* Sexually active subjects must agree to abstain or use double barrier contraception during the study
* Subjects must agree not to take any other medications during the course of the study without approval by the study investigators.
Exclusion Criteria:
* Abnormal screening labs (with the exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
* Creatinine clearance less than 90 ml/min as calculated by Cockcroft-Gault equation
* Hemoglobin \<12 mg/dL or hematocrit \< 36%
* Abnormal liver function tests, including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Albumin, and Alkaline Phosphatase
* Weight \< 34 kg
* History of renal dysfunction, liver dysfunction, congestive heart failure, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
* Pregnant or breast feeding
* On medications known to affect the reproductive axis within 3 months of the study (including oral contraceptive pills, metformin, and spironolactone)
* Are currently participating in another study or have been in one in the last 30 days.
* Subjects using restricted medication (see restrictions below) are excluded unless the subject's primary care provider approves stopping the medication.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT01427595
Study Brief:
Protocol Section:
NCT01427595