Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

NCT00575341 | Completed Phase 3

• 2 other identifiers: DHEA2000 - V18.03.2003Vorlagen-Nummer BfArM: 4020260
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Adrenal Insufficiency

Keywords

Central Adrenal Insufficiency; DHEA; Pubes

Outcome Measures

Primary Outcomes (1)

• Increase of pubes as measured by tanner stage

  one year

Secondary Outcomes (2)

• enhancement in well being and mood by psychometric tests

  one year

• normalization of the serum content of DHEA, androstanedione and testosterone

  one year

Study Arms (2)

1

ACTIVE COMPARATOR

substitution of DHEA-hormone, oral, once daily

Drug: Dehydroepiandrosterone

2

PLACEBO COMPARATOR

substitution of placebo, oral, once daily

Drug: placebo

Interventions

Dehydroepiandrosterone DRUG

25 mg DHEA, oral, once daily

1

placebo DRUG

placebo, oral, once daily

2

Eligibility Criteria

• Age: 13 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• additional pituitary hormon deficiencies (growth hormone, TSH, FSH, LH, prolactin, ADH)
• no scheduled change of the auxilliary medication during the clinical trial

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (4)

Universitaere Kinderklinik

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinik für Kinderheilkunde und Jugendmedizin

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetskinik für Kinder und Jugendliche

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinik und Poliklinik für Kinder und Jungendliche

Leipzig, Saxony, 04317, Germany

Location

Related Publications (6)

• 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.

  PMID: 11158009 BACKGROUND

• 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.

  PMID: 9253337 BACKGROUND

• 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.

  PMID: 10502590 BACKGROUND

• 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.

  PMID: 11134123 BACKGROUND

• 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.

  PMID: 11994339 BACKGROUND

• 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.

  PMID: 11847477 BACKGROUND

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Gerhard Binder, PD Dr. med.

  Children´s Hospital Tuebingen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: October 1, 2003
• Study Completion: April 1, 2007
• Last Updated: December 18, 2007

Record last verified: 2007-12

Locations

DE (4)