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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
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenal Insufficiency

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 9, 2007
    Last Updated
    May 9, 2007
    Sponsor
    University of Aarhus
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    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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