Status:
UNKNOWN
Adrenocortical Functions in Women With Nonclassical 21-hydroxylase Deficiency.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Adrenal Hyperplasia, Congenital
21-hydroxylase Deficiency
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The risk of adrenal insufficiency in patients with nonclassical congenital adrenal hyperplasia due to 21-hydroxylase deficiency is not well documented. Indication of cortisol replacement therapy in si...
Detailed Description
The primary end-point of the study is to evaluate the glucocorticoid function of the adrenal glands in women with nonclassical 21-hydroxylase deficiency (= patients) by comparing the maximal cortisol ...
Eligibility Criteria
Inclusion
- Groupe of patients:
- women aged 18-50 years with nonclassical 21-hydroxylase deficiency with homozygous or compound heterozygous mutations of CYP21A2 and plasma 17-hydroxyprogesterone concentration after stimulation with synacthen \>= 10ng/mL
- Groupe of healthy volunteers :
- age matched female healthy volunteers with plasma 17-hydroxyprogesterone concentration after stimulation with synacthen \< 2ng/mL
Exclusion
- treatment with oral or local glucocorticoids \< 1 year
- oral estroprogestative contraception \< 3 months
- spironolactone \< 3 months
- cyproterone acetate \< 3 months
- treatment modifying the activity of the renin - angiotensine - aldosterone system \< 2 weeks
- pregnancy and lactation
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01862380
Start Date
February 1 2013
End Date
November 1 2016
Last Update
September 29 2016
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94 275