Six Months DHEA Treatment in Female Adrenal Failure

May 9, 2007 updated by: University of Aarhus

Physiolocal Effects of 6 Months DHEA Substitutional Therapy in Female Adrenal Failure in a Randomised, Placebo Controlled and Overcrossed Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Neoplastic and thromboembolic disease,
  • Diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Jens S Christiansen, Professor, Medical Dept. M, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

May 9, 2007

First Submitted That Met QC Criteria

May 9, 2007

First Posted (Estimate)

May 10, 2007

Study Record Updates

Last Update Posted (Estimate)

May 10, 2007

Last Update Submitted That Met QC Criteria

May 9, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200110130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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