Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

Adrenal Insufficiency Clinical Trial

— DHEA2000  

Official title:

Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575341
• Other study ID #: DHEA2000 - V18.03.2003
• Secondary ID: Vorlagen-Nummer
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2007
• Last updated: December 17, 2007
• Start date: October 2003
• Est. completion date: April 2007

Study information

• Verified date: December 2007
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 26 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Drug:
• Dehydroepiandrosterone
25 mg DHEA, oral, once daily
• placebo
placebo, oral, once daily

Locations

Country	Name	City	State
Germany	Universitaetskinik für Kinder und Jugendliche	Erlangen	Bayern
Germany	Universitaere Kinderklinik	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinik und Poliklinik für Kinder und Jungendliche	Leipzig	Sachsen
Germany	Universitaetsklinik für Kinderheilkunde und Jugendmedizin	Tuebingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View Citation

Johannsson G, Burman P, Wirén L, Engström 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of pubes as measured by tanner stage		one year	No
Secondary	enhancement in well being and mood by psychometric tests		one year	No
Secondary	normalization of the serum content of DHEA, androstanedione and testosterone		one year	No