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Trial record 80 of 237 for:    PRASTERONE

Six Months DHEA Treatment in Female Adrenal Failure

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

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

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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

Resource links provided by the National Library of Medicine

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Neoplastic and thromboembolic disease,
  • Diabetes mellitus.

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 identifier (NCT number): NCT00471900

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

Layout table for additonal information Identifier: NCT00471900    
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
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors