Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adrenal Insufficiency

Intervention / Treatment
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* Drug: Dehydroepiandrosterone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>substitution of DHEA-hormone, oral, once daily | Drug: Dehydroepiandrosterone<br>* 25 mg DHEA, oral, once daily<br>|
| Placebo Comparator: 2<br>substitution of placebo, oral, once daily | Drug: placebo<br>* placebo, oral, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of pubes as measured by tanner stage |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enhancement in well being and mood by psychometric tests |  | one year | 
| normalization of the serum content of DHEA, androstanedione and testosterone |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Adrenal Insufficiency, DHEA, Pubes