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

December 17, 2007 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
substitution of DHEA-hormone, oral, once daily
Drug: Dehydroepiandrosterone
25 mg DHEA, oral, once daily
Placebo Comparator: 2
substitution of placebo, oral, once daily
Drug: placebo
placebo, oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase of pubes as measured by tanner stage
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
enhancement in well being and mood by psychometric tests
Time Frame: one year
one year
normalization of the serum content of DHEA, androstanedione and testosterone
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Study Director: Gerhard Binder, PD Dr. med., Children´s Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHEA2000 - V18.03.2003
  • Vorlagen-Nummer BfArM: 4020260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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