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Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia (CAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01771328
Recruitment Status : Unknown
Verified December 2016 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : January 18, 2013
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
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 (androstenedione and 17-hydroxyprogesterone profiles, and testosterone,adrenocorticotropic hormone(ACTH), cortisol, and bone markers), and to determine the required glucocorticoid doses. 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).

Condition or disease Intervention/treatment Phase
Adrenal Hyperplasia, Congenital Drug: Hydrocortisone Drug: Cortisone acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia
Study Start Date : February 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Active Comparator: hydrocortisone
Treatment B ( Solu-Cortef) the initial standard dose of 10mg/m2/24hrs. Hydrocortisone infusate will be given as Solu-Cortef Act-o-Vial 50mg/ml, produced by Pfizer. Treatment will take 4 months.
Drug: Hydrocortisone
Initial standard dose of 10mg/m2/24hrs administered by pump during the treatment period, it will take 4 months. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.
Other Name: Solu-Cortef

Active Comparator: cortisone acetate
Treatment A (Cortisone tbl.) is current treatment, i.e. glucocorticoid and mineralocorticoid replacement according to best clinical judgement. This treatment period will take 6 months.
Drug: Cortisone acetate
Patients will take this tables two times during day according to best clinical practice of therapy of congenital adrenal hyperplasia. Usually Cortisone 25 mg 1 tbl. in the morning and Cortisone 25 1/4 tbl. in the evening. This period will take 6 months.
Other Name: Cortisone

Primary Outcome Measures :
  1. Androgen levels [ Time Frame: 3 months ]
    Androgen levels as parameters of adequate suppression of androgen production

Secondary Outcome Measures :
  1. Steroid metabolism [ Time Frame: 4 months ]
    levels of ACTH

  2. bone metabolism [ Time Frame: 3 months ]
  3. fasting glucose [ Time Frame: 4 months ]
  4. body mass index [ Time Frame: 3 months ]
  5. Dual-energy X-ray absorptiometry (DXA) [ Time Frame: 6 months ]
    body composition, bone mineral density

  6. Subjective health status [ Time Frame: 3 months ]

  7. waist circumference [ Time Frame: 3 month ]

  8. hip circumference [ Time Frame: 3 months ]

  9. blood pressure [ Time Frame: 3 months ]
  10. fasting insulin [ Time Frame: 3-4 months ]
  11. glycated haemoglobin (Hb1AC) [ Time Frame: 4 months ]
  12. lipid levels [ Time Frame: 4 months ]
  13. c-reactive protein [ Time Frame: 4 months ]
  14. Steroid metabolism [ Time Frame: 4 months ]
    cortisol levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • verified salt-wasting CAH and simple virilizing CAH, on single prednisone, or hydrocortisone therapy.
  • In case of concomitant endocrine/autoimmune diseases these should be on stable treatment during the study period.

Exclusion Criteria:

  • Patients with diabetes mellitus on insulin pump treatment will not be included in this study
  • cardiovascular disease, active malignant disease and pregnancy, and pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns wart).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771328

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Contact: Kristian Løvås, MD, PhD +47 55977996 kral@helse-bergen.no
Contact: Katerina Simunkova, MD, PhD +47 55974603 katerina.simunkova@med.uib.no

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Haukeland Universitetssykehus, Department of Medicine Recruiting
Bergen, Norway, 5021
Contact: Kristian Løvås, MD, PhD    +4755977996    kral@helse-bergen.no   
Contact: Katerina Simunkova, MD, PhD    +4755974603    katerina.simunkova@med.uib.no   
Principal Investigator: Kristian Løvås, MD, PhD         
Sub-Investigator: Marianne Øksnes, MD         
Sub-Investigator: Ingrid Nermoen, MD         
Sub-Investigator: Paal Methlie, MD         
Sub-Investigator: Eystein S Husebye, prof., MD         
Principal Investigator: Katerina Simunkova, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
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Principal Investigator: Kristian Løvås, MD, PhD Haukeland University Hospital, Department of Medicine
Additional Information:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01771328    
Other Study ID Numbers: 2012/749
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Keywords provided by Haukeland University Hospital:
Adrenal Hyperplasia, Congenital
Additional relevant MeSH terms:
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Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents