Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency (DHEA2000)

University Hospital Tuebingen

Status and phase: Completed; Phase 3

Conditions: Adrenal Insufficiency

Treatments: Drug: placebo; Drug: Dehydroepiandrosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT00575341

Vorlagen-Nummer BfArM: 4020260

DHEA2000 - V18.03.2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 13 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

23 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

substitution of DHEA-hormone, oral, once daily

Treatment:

Drug: Dehydroepiandrosterone

2

Placebo Comparator group

Description:

substitution of placebo, oral, once daily

Treatment:

Drug: placebo