Trial record 11 of 65 for:    "21-hydroxylase deficiency"

Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia (CAH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Haukeland University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: January 10, 2013
Last updated: March 27, 2015
Last verified: November 2013

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 Intervention Phase
Adrenal Hyperplasia, Congenital
Drug: Hydrocortisone
Drug: Cortisone acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Androgen levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Androgen levels as parameters of adequate suppression of androgen production

Secondary Outcome Measures:
  • Steroid metabolism [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    levels of ACTH

  • bone metabolism [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Dual-energy X-ray absorptiometry (DXA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    body composition, bone mineral density

  • Subjective health status [ Time Frame: 3 months ] [ Designated as safety issue: No ]

  • waist circumference [ Time Frame: 3 month ] [ Designated as safety issue: No ]

  • hip circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]

  • blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • fasting insulin [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
  • glycated haemoglobin (Hb1AC) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • lipid levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • c-reactive protein [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Steroid metabolism [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    cortisol levels

Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01771328

Contact: Kristian Løvås, MD, PhD +47 55977996
Contact: Katerina Simunkova, MD, PhD +47 55974603

Haukeland Universitetssykehus, Department of Medicine Recruiting
Bergen, Norway, 5021
Contact: Kristian Løvås, MD, PhD    +4755977996   
Contact: Katerina Simunkova, MD, PhD    +4755974603   
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
Principal Investigator: Kristian Løvås, MD, PhD Haukeland University Hospital, Department of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Haukeland University Hospital Identifier: NCT01771328     History of Changes
Other Study ID Numbers: 2012/749
Study First Received: January 10, 2013
Last Updated: March 27, 2015
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Adrenal Hyperplasia, Congenital

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Gonadal Disorders
Metabolic Diseases
Metabolism, Inborn Errors
Pathologic Processes
Steroid Metabolism, Inborn Errors
Urogenital Abnormalities
Cortisol succinate
Cortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 08, 2015