Clinical Trial: Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Dehydroepiandrosterone(DHEA) Substitution in Adolescent and Young Women With Central Adrenal Insufficiency. A Multicenter, Randomised Double Blind Trial
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 Summary: 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.
Sponsor: University Hospital Tuebingen
Current Primary Outcome: Increase of pubes as measured by tanner stage [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- enhancement in well being and mood by psychometric tests [ Time Frame: one year ]
- normalization of the serum content of DHEA, androstanedione and testosterone [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: University Hospital Tuebingen
Dates:
Date Received: December 14, 2007
Date Started: October 2003
Date Completion:
Last Updated: December 17, 2007
Last Verified: December 2007
