Six Months DHEA Treatment in Female Adrenal Failure
Primary Purpose
Adrenal Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dehydroepiandrosterone (DHEA)
Sponsored by
About this trial
This is an interventional treatment trial for Adrenal Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Female,
- Adrenal insuficiency,
- Stable and safe anticonception,
- Stable hydrocortison substituation treatment.
Exclusion Criteria:
- Neoplastic and thromboembolic disease,
- Diabetes mellitus.
Sites / Locations
Outcomes
Primary Outcome Measures
Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471900
Brief Title
Six Months DHEA Treatment in Female Adrenal Failure
Official Title
Physiolocal Effects of 6 Months DHEA Substitutional Therapy in Female Adrenal Failure in a Randomised, Placebo Controlled and Overcrossed Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dehydroepiandrosterone (DHEA)
Primary Outcome Measure Information:
Title
Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.
Time Frame
six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female,
Adrenal insuficiency,
Stable and safe anticonception,
Stable hydrocortison substituation treatment.
Exclusion Criteria:
Neoplastic and thromboembolic disease,
Diabetes mellitus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens S Christiansen, Professor
Organizational Affiliation
Medical Dept. M, Aarhus University Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Six Months DHEA Treatment in Female Adrenal Failure
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