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Six Months DHEA Treatment in Female Adrenal Failure

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ClinicalTrials.gov Identifier: NCT00471900
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : May 10, 2007
Sponsor:
Information provided by:
University of Aarhus

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Adrenal Insufficiency Drug: dehydroepiandrosterone (DHEA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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.
Study Start Date : October 2001
Actual Study Completion Date : February 2003

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

Eligibility Criteria
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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
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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
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Study Director: Jens S Christiansen, Professor Medical Dept. M, Aarhus University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00471900     History of Changes
Other Study ID Numbers: 200110130
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Dehydroepiandrosterone
 Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors