Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Dehydroepiandrosterone; Epinephrine; Epinephryl borate; Racepinephrine

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