CClinicalTrials.gg
Sign In
CompletedNCT00575341DHEA2000Updated Dec 18, 2007

Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

A Phase 3 interventional study of Dehydroepiandrosterone and placebo in Adrenal Insufficiency, sponsored by University Hospital Tuebingen. Completed at 4 sites in Germany. Open to female participants aged 13 Years to 26 Years. Per ClinicalTrials.gov, last updated 2007-12-18.

Sponsored by University Hospital Tuebingen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
13 Years to 26 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Adrenal Insufficiency

Browse trials for

Keywords

  • Central Adrenal Insufficiency
  • DHEA
  • Pubes
03

In context

Adrenal Insufficiency

132 studies on the registry are indexed under Adrenal Insufficiency; 26 are open to participants now.

This study's enrollment of 23 is below the median of 37 across 70 interventional studies indexed under Adrenal Insufficiency.

Browse Adrenal Insufficiency studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 26 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    1

    substitution of DHEA-hormone, oral, once daily

    Drug: Dehydroepiandrosterone

  • Placebo comparator
    2

    substitution of placebo, oral, once daily

    Drug: placebo

Interventions

  • DrugDehydroepiandrosterone

    25 mg DHEA, oral, once daily

  • Drugplacebo

    placebo, oral, once daily

06

What researchers measure

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

07

Study locations

4 sites
  • Universitaere Kinderklinik
    Heidelberg, Baden-Wuerttemberg 69120, Germany
  • Universitaetsklinik für Kinderheilkunde und Jugendmedizin
    Tuebingen, Baden-Wuerttemberg 72076, Germany
  • Universitaetskinik für Kinder und Jugendliche
    Erlangen, Bayern 91054, Germany
  • Universitaetsklinik und Poliklinik für Kinder und Jungendliche
    Leipzig, Sachsen 04317, Germany
08

References and documents

Publications

  • Miller KK, Sesmilo G, Schiller A, Schoenfeld D, Burton S, Klibanski A. Androgen deficiency in women with hypopituitarism. J Clin Endocrinol Metab. 2001 Feb;86(2):561-7. doi: 10.1210/jcem.86.2.7246. PubMed 11158009 ↗
  • Young J, Couzinet B, Nahoul K, Brailly S, Chanson P, Baulieu EE, Schaison G. Panhypopituitarism as a model to study the metabolism of dehydroepiandrosterone (DHEA) in humans. J Clin Endocrinol Metab. 1997 Aug;82(8):2578-85. doi: 10.1210/jcem.82.8.4157. PubMed 9253337 ↗
  • Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20. doi: 10.1056/NEJM199909303411401. PubMed 10502590 ↗
  • Hunt PJ, Gurnell EM, Huppert FA, Richards C, Prevost AT, Wass JA, Herbert J, Chatterjee VK. Improvement in mood and fatigue after dehydroepiandrosterone replacement in Addison's disease in a randomized, double blind trial. J Clin Endocrinol Metab. 2000 Dec;85(12):4650-6. doi: 10.1210/jcem.85.12.7022. PubMed 11134123 ↗
  • Johannsson G, Burman P, Wiren L, Engstrom BE, Nilsson AG, Ottosson M, Jonsson B, Bengtsson BA, Karlsson FA. Low dose dehydroepiandrosterone affects behavior in hypopituitary androgen-deficient women: a placebo-controlled trial. J Clin Endocrinol Metab. 2002 May;87(5):2046-52. doi: 10.1210/jcem.87.5.8494. PubMed 11994339 ↗
  • Wit JM, Langenhorst VJ, Jansen M, Oostdijk WA, van Doorn J. Dehydroepiandrosterone sulfate treatment for atrichia pubis. Horm Res. 2001;56(3-4):134-9. doi: 10.1159/000048106. PubMed 11847477 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00575341
Lead sponsor
University Hospital Tuebingen
First posted
Dec 18, 2007
Start date
Oct 2003
Completion
Apr 2007
Last update
Dec 18, 2007

Study contacts

Gerhard Binder, PD Dr. med.
study director · Children´s Hospital Tuebingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Adrenal Insufficiency→

Other studies from this sponsor

University Hospital Tuebingen

Start the discussion