A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasia

• Conditions: Congenital adrenal hyperplasia (CAH); MedDRA version: 14.1Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-005822-23-NO
• Lead Sponsor: Haukeland University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-25
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Verified salt-wasting CAH
Age 18-60
Written informed consent. If the patient is between 15-16 years old both the patient and the parents will have to give informed consent.
In case of concomitant endocrine/autoimmune diseases these should be on stable treatment during the study period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with diabetes mellitus on insulin pump treatment will not be included in this study. Other exclusion criteria are cardiovascular disease, malignant disease and pregnancy, and pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns wart). The patients should not take grapefruit juice the last two weeks before or during the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified