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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02552251
Eligibility Criteria:
Inclusion Criteria:
* Pubescent women over 18 in genital activity (premenopausal)
* Suffering from congenital adrenal hyperplasia in its classical form with salt loss or pure virilizing
* Patients who have presented signs of congenital adrenal hyperplasia in its classical form (salt wasting syndrome and / or neonatal masculinization) with elevation of 17 OH progesterone with diagnosis of enzyme block 21 hydroxylase.
* Patients currently treated by: 1 or 2 Oral compound glucocorticoid as replacement and suppressive therapy + 1 mineralocorticoid if necessary with effective control of substitution + possibly by estrogen-progestin pill.
Exclusion Criteria:
* Liver disease, kidney, bone, diabetes, severe dyslipidemia, pregnancy
* Postmenopausal women, age over 55 years
* Concomitant therapy: glucocorticoids supra-physiological doses for other indications, bisphosphonates, vitamin D, oral antidiabetic agents or insulin, lipid lowering agents (eg inflammatory disease, asthma, systemic disease ... ..).
* participation of the subject to another biomedical research protocol for this study
* Inability to submit to medical monitoring study for geographical, social or psychological.
* Severe calorie diet planned or carried out during the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02552251
Study Brief:
Protocol Section:
NCT02552251