COrticosteroid in Congenital Adrenal Hyperplasia

• Register: ClinicalTrials.gov
• Last refreshed on: 28 September 2015
• Main ID: NCT02552251
• Date of registration: 27/07/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Caen
• Public title: COrticosteroid in Congenital Adrenal Hyperplasia COCA
• Scientific title: Comparative Study of the Use of Glucocorticoids in the Treatment of Congenital Adrenal Hyperplasia in Its Classical Form
• Date of first enrolment: August 2012
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02552251
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Yves REZNIK, MD, PhD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Congenital Adrenal Hyperplasia

Intervention(s)

Biological: metabolic balance measurements

Biological: bone balance measurements

Behavioral: quality of life assessment

Biological: Hormonal balance measurements

Primary Outcome(s)

hormonal parameters [Time Frame: change over baseline, week 8, week 16, week 24]

Secondary Outcome(s)

metabolic parameters: [Time Frame: change over baseline, week 8, week 16, week 24]

parameters of bone turnover: [Time Frame: change over baseline, week 8, week 16, week 24]

Quality of Life [Time Frame: change over baseline, week 8, week 16, week 24]

Secondary ID(s)

11-059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors