Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

NCT ID: NCT00442390

Last Updated: 2007-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-01-31

Brief Summary

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Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.

Detailed Description

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Conditions

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Addison Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hydrocortisone substitution therapy versus withdrawal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female adrenal failure
* Age 18-50
* Written informed content

Exclusion Criteria

* Diabetes mellitus
* Cancer
* Thromboembolic events
* Pregnancy and lactation
* Heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Jens Juel Christiansen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Claus H Gravholt, MD

Role: STUDY_CHAIR

University of Aarhus

Christian B Djurhuus, PhD

Role: STUDY_CHAIR

University of Aarhus

Per Iversen, PhD

Role: STUDY_CHAIR

University of Aarhus

Jens S Christiansen, Professor

Role: STUDY_CHAIR

University of Aarhus

Ole Schmidt, Professor

Role: STUDY_CHAIR

University of Aarhus

Jørgen Weeke, Professor

Role: STUDY_CHAIR

University of Aarhus

Jens OL Jørgensen, MD

Role: STUDY_CHAIR

University of Aarhus

Niels Møller, Professor

Role: STUDY_DIRECTOR

University of Aarhus

Other Identifiers

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1998/4375

Identifier Type: -

Identifier Source: org_study_id

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