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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575341
First Posted: December 18, 2007
Last Update Posted: December 18, 2007
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.
Information provided by:
University Hospital Tuebingen
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Increase of pubes as measured by tanner stage [ Time Frame: one year ]

Secondary Outcome Measures:
  • enhancement in well being and mood by psychometric tests [ Time Frame: one year ]
  • normalization of the serum content of DHEA, androstanedione and testosterone [ Time Frame: one year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 26 Years   (Child, Adult)
Sexes 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
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): 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
First Submitted: December 14, 2007
First Posted: December 18, 2007
Last Update Posted: December 18, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Dehydroepiandrosterone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Adjuvants, Immunologic
Immunologic Factors