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Six Months DHEA Treatment in Female Adrenal Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471900
First Posted: May 10, 2007
Last Update Posted: May 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Aarhus
  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
Intervention Model: Crossover Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471900


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

ClinicalTrials.gov Identifier: NCT00471900     History of Changes
Other Study ID Numbers: 200110130
First Submitted: May 9, 2007
First Posted: May 10, 2007
Last Update Posted: May 10, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs