Clinical trial NCT00575341: Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency
Official title: Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adrenal Insufficiency
Keywords: Central Adrenal Insufficiency
DHEA
Pubes
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 23
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Increase of pubes as measured by tanner stage
timeFrame: one year
Secondary outcomes:
measure: enhancement in well being and mood by psychometric tests
timeFrame: one year
measure: normalization of the serum content of DHEA, androstanedione and testosterone
timeFrame: one year
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitaere Kinderklinik
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinik für Kinderheilkunde und Jugendmedizin
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetskinik für Kinder und Jugendliche
state: Bayern
city: Leipzig
country: Germany
facility: Universitaetsklinik und Poliklinik für Kinder und Jungendliche
state: Sachsen
Study officials:
affiliation: Children´s Hospital Tuebingen
name: Gerhard Binder, PD Dr. med.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.