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

CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005822-23-NO

Enrollment

Registered

2013-02-25

Start date

2012-10-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital adrenal hyperplasia (CAH) MedDRA version: 14.1 Level: LLT Classification code 10010323 Term: Congenital adrenal hyperplasia System Organ Class: 100000004850

Interventions

Trade Name: Solu-Cortef Pharmaceutical Form: Powder and solvent for solution for infusion Trade Name: Cortison Pharmaceutical Form: Tablet Trade Name: Prednisolone Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method was recently applied to treat a patient through a critical phase of puberty. This is a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is to determine the effects of CSHI on metabolic parameters (androstendione and 17-hydroxyprogesterone profiles, and testosterone, ACTH, cortisol, and bone markers), and to determine the required glucocorticoid doses. ;Secondary Objective: Secondary objectives are to determine effects on clinical status, body weight, blood pressure and other metabolic parameters, as well as on subjective health status (AddiQoL, SF36). ;Primary end point(s): Androgen levels (in particular androstendione and 17-hydroxyprogesterone profiles) as parameters of adequate suppression of androgen production;Timepoint(s) of evaluation of this end point: After 2 and 3 months of treatment in each period (arm A and B)	—

Measure

Time frame

Main Objective: The conventional glucocorticoid replacement therapy in congenital adrenal hyperplasia (CAH) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This method was recently applied to treat a patient through a critical phase of puberty. This is a clinical trial aiming to evaluate CSHI treatment in patients with CAH. The main objective is to determine the effects of CSHI on metabolic parameters (androstendione and 17-hydroxyprogesterone profiles, and testosterone, ACTH, cortisol, and bone markers), and to determine the required glucocorticoid doses. ;Secondary Objective: Secondary objectives are to determine effects on clinical status, body weight, blood pressure and other metabolic parameters, as well as on subjective health status (AddiQoL, SF36). ;Primary end point(s): Androgen levels (in particular androstendione and 17-hydroxyprogesterone profiles) as parameters of adequate suppression of androgen production;Timepoint(s) of evaluation of this end point: After 2 and 3 months of treatment in each period (arm A and B)

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Secondary

Measure	Time frame
Secondary end point(s): The effect of glucocorticoid replacement on - Steroid and bone metabolism, i.e ACTH, cortisol, bone markers - Cardiovascular risk markers such as fasting glucose/insulin, Hb1Ac, lipid levels, CRP - Clinical status (BMI, waist circumference and blood pressure) - DXA (body composition, bone mineral density) - Subjective health status (SF-36, AddiQoL) ;Timepoint(s) of evaluation of this end point: After 2 and 3 months of treatment in each period (arm A and B)	—

Measure

Time frame

Secondary end point(s): The effect of glucocorticoid replacement on - Steroid and bone metabolism, i.e ACTH, cortisol, bone markers - Cardiovascular risk markers such as fasting glucose/insulin, Hb1Ac, lipid levels, CRP - Clinical status (BMI, waist circumference and blood pressure) - DXA (body composition, bone mineral density) - Subjective health status (SF-36, AddiQoL) ;Timepoint(s) of evaluation of this end point: After 2 and 3 months of treatment in each period (arm A and B)

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Countries

Norway, Sweden

Contacts

Public ContactKristian Løvås

Haukeland University Hospital

kral@helse-bergen.no4755977996

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026