Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00575341

Acronym

DHEA2000

Enrollment

Registered

2007-12-18

Start date

2003-10-31

Completion date

2007-04-30

Last updated

2007-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency

Keywords

Central Adrenal Insufficiency, DHEA, Pubes

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.

Interventions

DRUGDehydroepiandrosterone

25 mg DHEA, oral, once daily

DRUGplacebo

placebo, oral, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 26 Years

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

Design outcomes

Primary

Measure	Time frame
Increase of pubes as measured by tanner stage	one year

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026