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Six Months DHEA Treatment in Female Adrenal Failure

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00471900
First received: May 9, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects of physiologically DHEA substitution is investigated in the model of female adrenal failure.


Condition Intervention
Adrenal Insufficiency
 Drug: dehydroepiandrosterone (DHEA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Physiolocal Effects of 6 Months DHEA Substitutional Therapy in Female Adrenal Failure in a Randomised, Placebo Controlled and Overcrossed Study.

Resource links provided by NLM:

Drug Information available for: Prasterone
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme. [ Time Frame: six months ]

Enrollment: 10
Study Start Date: October 2001
Study Completion Date: February 2003
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female,
  • Adrenal insuficiency,
  • Stable and safe anticonception,
  • Stable hydrocortison substituation treatment.

Exclusion Criteria:

  • Neoplastic and thromboembolic disease,
  • Diabetes mellitus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471900

Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Jens S Christiansen, Professor Medical Dept. M, Aarhus University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00471900     History of Changes
Other Study ID Numbers: 200110130
Study First Received: May 9, 2007
Last Updated: May 9, 2007
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013