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Completed

NCT Number: NCT00575341

Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

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.

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Key information

Conditions

Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases

Age range

13 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universitaere Kinderklinik, Heidelberg, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dehydroepiandrosterone

Drug

25 mg DHEA, oral, once daily

Placebo

Drug

placebo, oral, once daily

Primary outcomes

  1. Increase of pubes as measured by tanner stage

    Time frame: one year

Secondary outcomes

  1. enhancement in well being and mood by psychometric tests

    Time frame: one year

  2. normalization of the serum content of DHEA, androstanedione and testosterone

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: DHEA2000

Important dates

Study start
2003
Study completion
2007
First posted
Dec 18, 2007
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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