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Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency (DHEA2000)

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00575341
First received: December 14, 2007
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.


Condition Intervention Phase
Adrenal Insufficiency
 Drug: Dehydroepiandrosterone
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Increase of pubes as measured by tanner stage [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • enhancement in well being and mood by psychometric tests [ Time Frame: one year ] [ Designated as safety issue: No ]
  • normalization of the serum content of DHEA, androstanedione and testosterone [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2003
Study Completion Date: April 2007
Arms Assigned Interventions
Active Comparator: 1
substitution of DHEA-hormone, oral, once daily
 Drug: Dehydroepiandrosterone
25 mg DHEA, oral, once daily
Placebo Comparator: 2
substitution of placebo, oral, once daily
 Drug: placebo
placebo, oral, once daily

Detailed Description:

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. After randomization they either get DHEA or placebo for 12 months daily. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.

  Eligibility

Ages Eligible for Study:   13 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female gender
  • age between 13 and 26 Years
  • breast developement minimal Tanner stage 3
  • serum content of DHEAS less than 400 ng/ml
  • central hypocortisolism
  • 2 additional pituitary hormon deficiencies (growth hormone, TSH, FSH, LH, prolactin, ADH)
  • no scheduled change of the auxilliary medication during the clinical trial

Exclusion Criteria:

  • initial diagnosis of a cerebral tumor less than one year
  • constitution after cerebral exposure with over 30 gray
  • craniopharyngioma with hypothalamic defect syndrome or relapse
  • blindness
  • mental retardation or psychiatric disorder
  • systemic disorder, diabetes mellitus, cardiovascular disease, liver disease requiring treatment
  • elevated liver enzyme levels
  • pregnancy
  • in case of no hypogonadism: no secure contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575341

Locations
Germany
Universitaere Kinderklinik
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitaetsklinik für Kinderheilkunde und Jugendmedizin
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Universitaetskinik für Kinder und Jugendliche
Erlangen, Bayern, Germany, 91054
Universitaetsklinik und Poliklinik für Kinder und Jungendliche
Leipzig, Sachsen, Germany, 04317
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Study Director: Gerhard Binder, PD Dr. med. Children´s Hospital Tuebingen
  More Information

Publications:

Responsible Party: PD Dr. med. Gerhard Binder, University-Children's Hospital Tuebingen, Pediatric Endocrinology
ClinicalTrials.gov Identifier: NCT00575341     History of Changes
Other Study ID Numbers: DHEA2000 - V18.03.2003, Vorlagen-Nummer BfArM: 4020260
Study First Received: December 14, 2007
Last Updated: December 17, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
Central Adrenal Insufficiency
DHEA
Pubes

Additional relevant MeSH terms:
Adrenal Insufficiency
Addison Disease
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013