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

Primary Purpose

Adrenal Insufficiency

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Dehydroepiandrosterone
placebo
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenal Insufficiency focused on measuring Central Adrenal Insufficiency, DHEA, Pubes

Eligibility Criteria

13 Years - 26 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaere Kinderklinik
  • Universitaetsklinik für Kinderheilkunde und Jugendmedizin
  • Universitaetskinik für Kinder und Jugendliche
  • Universitaetsklinik und Poliklinik für Kinder und Jungendliche

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

substitution of DHEA-hormone, oral, once daily

substitution of placebo, oral, once daily

Outcomes

Primary Outcome Measures

Increase of pubes as measured by tanner stage

Secondary Outcome Measures

enhancement in well being and mood by psychometric tests
normalization of the serum content of DHEA, androstanedione and testosterone

Full Information

First Posted
December 14, 2007
Last Updated
December 17, 2007
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00575341
Brief Title
Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency
Acronym
DHEA2000
Official Title
Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency
Keywords
Central Adrenal Insufficiency, DHEA, Pubes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
substitution of DHEA-hormone, oral, once daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
substitution of placebo, oral, once daily
Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone
Intervention Description
25 mg DHEA, oral, once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, oral, once daily
Primary Outcome Measure Information:
Title
Increase of pubes as measured by tanner stage
Time Frame
one year
Secondary Outcome Measure Information:
Title
enhancement in well being and mood by psychometric tests
Time Frame
one year
Title
normalization of the serum content of DHEA, androstanedione and testosterone
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Binder, PD Dr. med.
Organizational Affiliation
Children´s Hospital Tuebingen
Official's Role
Study Director
Facility Information:
Facility Name
Universitaere Kinderklinik
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinik für Kinderheilkunde und Jugendmedizin
City
Tuebingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetskinik für Kinder und Jugendliche
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinik und Poliklinik für Kinder und Jungendliche
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04317
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
11158009
Citation
Miller KK, Sesmilo G, Schiller A, Schoenfeld D, Burton S, Klibanski A. Androgen deficiency in women with hypopituitarism. J Clin Endocrinol Metab. 2001 Feb;86(2):561-7. doi: 10.1210/jcem.86.2.7246.
Results Reference
background
PubMed Identifier
9253337
Citation
Young J, Couzinet B, Nahoul K, Brailly S, Chanson P, Baulieu EE, Schaison G. Panhypopituitarism as a model to study the metabolism of dehydroepiandrosterone (DHEA) in humans. J Clin Endocrinol Metab. 1997 Aug;82(8):2578-85. doi: 10.1210/jcem.82.8.4157.
Results Reference
background
PubMed Identifier
10502590
Citation
Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20. doi: 10.1056/NEJM199909303411401.
Results Reference
background
PubMed Identifier
11134123
Citation
Hunt PJ, Gurnell EM, Huppert FA, Richards C, Prevost AT, Wass JA, Herbert J, Chatterjee VK. Improvement in mood and fatigue after dehydroepiandrosterone replacement in Addison's disease in a randomized, double blind trial. J Clin Endocrinol Metab. 2000 Dec;85(12):4650-6. doi: 10.1210/jcem.85.12.7022.
Results Reference
background
PubMed Identifier
11994339
Citation
Johannsson G, Burman P, Wiren L, Engstrom BE, Nilsson AG, Ottosson M, Jonsson B, Bengtsson BA, Karlsson FA. Low dose dehydroepiandrosterone affects behavior in hypopituitary androgen-deficient women: a placebo-controlled trial. J Clin Endocrinol Metab. 2002 May;87(5):2046-52. doi: 10.1210/jcem.87.5.8494.
Results Reference
background
PubMed Identifier
11847477
Citation
Wit JM, Langenhorst VJ, Jansen M, Oostdijk WA, van Doorn J. Dehydroepiandrosterone sulfate treatment for atrichia pubis. Horm Res. 2001;56(3-4):134-9. doi: 10.1159/000048106.
Results Reference
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Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

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