Prospective intervention trial with adjuvant metformin in girls and boys with classic congenital adrenal hyperplasia.

Phase 1

• Conditions: congenital adrenal hyperplasia (CAH); MedDRA version: 16.1Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-002395-40-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-19
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients: Girls and boys with classic CAH due to 21-hydroxylase deficiency (salt-wasting” and simple virilizing” forms), reaching the age of 8 years (girls) and 9 years (boys) in the period 2014 – 2018.

Controls: Girls and boys with classic CAH due to 21-hydroxylase deficiency (salt-wasting” and simple virilizing” forms), who are between 8 (girls) or 9 (boys) and 16 years at start of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Affected children on glucocorticoid treatment other than HC.
Mental retardation (IQ<70), syndromic patients.

Study & Design

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