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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02155933
Eligibility Criteria:
Inclusion Criteria:
* Early and late pubertal girls with normal androgens
* Early and late pubertal girls with hyperandrogenemia
* All subjects will be girls from pre-puberty (Stage 1 breast development and pubic hair growth but at least 7 years old) to 7 years post menarche.
Exclusion Criteria:
* Pregnancy
* Inability to comprehend what will be done during the study or why it will be done
* Hemoglobin \<11.5 g/dL for non-African American subjects; Hemoglobin \< 11.0 g/dL for African American subjects
* Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
* Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
* Total bilirubin \> 1.5 times upper limit of normal (i.e., confirmed on repeat)
* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
* Untreated hypo- or hyperthyroidism (reflected by persistently abnormal TSH values)
* Total testosterone \> 200 ng/dl
* Basal (follicular) 17-OHP \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
* DHEA-S \> 800 mcg/dl
* Elevation of prolactin \> 2 times upper limit of normal
* Weight less than 25 kg
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT02155933
Study Brief:
Protocol Section:
NCT02155933