NCT00444119

Brief Summary

The purpose of this survey is to assess patients with chronic primary or secondary adrenal failure regarding subjective health status, incidence and causes of adrenal crisis, hormone replacement regimens and concomitant endocrine or non endocrine disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2004

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
Last Updated

March 7, 2007

Status Verified

March 1, 2007

First QC Date

March 5, 2007

Last Update Submit

March 5, 2007

Conditions

Adrenal InsufficiencyAddison's Disease

Keywords

adrenal insufficiencysubjective health statusquality of lifeadrenal crisishormone replacementDHEA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • chronic adrenal failure with disease duration \> 12 months and hormone replacement therapy for cortisol deficiency

You may not qualify if:

  • adrenal insufficiency due to adrenocortical carcinoma
  • AI due to long-term pharmacological glucocorticoid treatment
  • glucocortiocid doses above 7.5 mg prednisolone equivalent for other reasons than AI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Medicine, Gastroenterology, Hepatology and Endocrinology, Charité Campus Mitte, Charité, University Medicine Berlin

Berlin, D-10117, Germany

Location

University of Wuerzburg, Dept of Medicine - Endocrine and Diabetes unit

Würzburg, D-97080, Germany

Location

Related Publications (1)

  • Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.

    PMID: 17684047DERIVED

MeSH Terms

Conditions

Adrenal InsufficiencyAddison Disease

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bruno Allolio, MD

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 7, 2007

Study Start

May 1, 2004

Study Completion

April 1, 2005

Last Updated

March 7, 2007

Record last verified: 2007-03

Locations

DE(2)