Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

University Hospital Tuebingen23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Adrenal Insufficiency

Interventions

DehydroepiandrosteroneDRUG

25 mg DHEA, oral, once daily

placeboDRUG

placebo, oral, once daily

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 26 Years

Medical Language ↔ Plain English

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

Locations (4)

Universitaere Kinderklinik

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinik für Kinderheilkunde und Jugendmedizin

Tübingen, Baden-Wurttemberg, Germany

Universitaetskinik für Kinder und Jugendliche

Erlangen, Bavaria, Germany

Universitaetsklinik und Poliklinik für Kinder und Jungendliche

Leipzig, Saxony, Germany

Outcomes

Primary Outcomes

Increase of pubes as measured by tanner stage

Time frame: one year

Secondary Outcomes

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

Data from ClinicalTrials.gov

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