Six Months DHEA Treatment in Female Adrenal Failure - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00471900

Purpose

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.

Condition	Intervention
Adrenal Insufficiency	Drug: dehydroepiandrosterone (DHEA)

Genetics Home Reference related topics: X-linked adrenoleukodystrophy

Drug Information available for: Dehydroepiandrosterone sulfate Prasterone Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Physiolocal Effects of 6 Months DHEA Substitutional Therapy in Female Adrenal Failure in a Randomised, Placebo Controlled and Overcrossed Study.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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

Enrollment:	10
Study Start Date:	October 2001
Study Completion Date:	February 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Neoplastic and thromboembolic disease,
Diabetes mellitus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471900

Sponsors and Collaborators

University of Aarhus

Investigators

Study Director:

Jens S Christiansen, Professor

Medical Dept. M, Aarhus University Hospital

More Information

Study ID Numbers:	200110130
Study First Received:	May 9, 2007
Last Updated:	May 9, 2007
ClinicalTrials.gov Identifier:	NCT00471900
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Adrenal Insufficiency
Addison's disease
Autoimmune Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Dehydroepiandrosterone
Hypoadrenalism

Adrenal gland hypofunction
Adrenoleukodystrophy
Addison Disease
Endocrinopathy
Epinephrine
X-linked adrenoleukodystrophy

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009