Evaluation of Circadian Hormonal Balance: LC-MS/MS Measurement of Salivary and Serum Steroids in Patients With Congenital Adrenal Hyperplasia
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Conditions studied: Congenital Adrenal Hyperplasia, Adrenal Insufficiency, Hyperandrogenism; 21-hydroxylase Deficiency
In brief
In congenital adrenal hyperplasia (CAH), lifelong hormone replacement therapy is required to treat adrenal insufficiency and to reduce elevated androgen levels. This is essential to ensure "normal" growth and puberty. Replacement therapy includes hydrocortisone and 9α-fludrocortisone acetate (as a mineralocorticoid substitute). Defining appropriate criteria for evaluating therapeutic goals is a key component of patient follow-up. Currently, monitoring is generally limited to the quantification of serum 17-hydroxyprogesterone (17OHP), testosterone (T) and delta-4 androstenedione (D4), measured in the morning after an overnight fast and before the morning hydrocortisone dose. However, such single-point serum measurements do not take into account the circadian rhythm of these steroids. The objective of the study is to evaluate correlations between steroid levels (21-deoxycortisol, 17-hydroxyprogesterone, testosterone, delta-4 androstenedione, and cortisol) measured by LC-MS/MS in multiple at-home self-collected saliva samples and those measured in serum during routine monitoring.
Key facts
- Study ID
- NCT07718230
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 50
- Starts
- 2026-09-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged 6 years or older
- Confirmed diagnosis of congenital adrenal hyperplasia treated with glucocorticoids
- Signed informed consent provided by legal guardians
- Affiliation to a national health insurance system
You may not qualify if…
- Patients younger than 6 years of age
- Lesions of the oral mucosa that could interfere with saliva sampling
- Inability to provide the patient or legal representatives with appropriate study information (e.g., poor understanding of French)
- Underage parents
- Lack of affiliation with a social security/health insurance system
Where it is running
- Service des Explorations Fonctionnelles Endocriniennes, Hôpital Armand Trousseau — Paris, France
Full record on ClinicalTrials.gov
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