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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
This study has been completed.
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Center for Research Resources (NCRR)
University of California, Los Angeles
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004313
  Purpose

OBJECTIVES:

I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).


Condition Intervention Phase
Addison's Disease
Drug: dehydroepiandrosterone
Phase III

Genetics Home Reference related topics: beta-ketothiolase deficiency L1 syndrome leukoencephalopathy with vanishing white matter megalencephalic leukoencephalopathy with subcortical cysts succinic semialdehyde dehydrogenase deficiency X-linked adrenoleukodystrophy
MedlinePlus related topics: Addison's Disease
Drug Information available for: Prasterone Dehydroepiandrosterone sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 40
Study Start Date: August 1995
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by age.

Patients are randomly assigned to androgen replacement therapy with daily dehydroepiandrosterone (DHEA) or placebo for 6 months. All patients may receive 6 additional months of DHEA following randomized therapy. Women on hormonal replacement therapy may receive concurrent conjugated estrogens or oral medroxyprogesterone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Primary adrenal insufficiency (Addison's disease) Serum dehydroepiandrosterone less than 0.5 nmol/L --Prior/Concurrent Therapy-- No concurrent investigational drug Stable glucocorticoid/mineralocorticoid dose over past year required --Patient Characteristics-- Hepatic: No hepatic disease Cardiovascular: No vascular disease No thrombotic disorder No angina No elevated blood pressure on 2 readings taken 15 minutes apart in 1 visit, i.e.: Systolic greater than 165 mm Hg OR Diastolic greater than 95 mm Hg Other: No clinically significant medical abnormality No gallbladder disease No malignancy No estrogen- or androgen-dependent neoplasia Benign prostatic hyperplasia eligible No other endocrine disease Controlled thyroid disease with normal thyroid-stimulating hormone eligible Mammogram required within 1 year prior to entry for women aged 40 and over No clinically significant abnormality No undiagnosed vaginal or uterine bleeding within 6 months prior to entry Pap smear required within 1 year prior to entry No dysplasia (squamous intraepithelial lesion low-grade or higher)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004313

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Study Chair: Samuel S. C. Yen University of California, Los Angeles
  More Information

No publications provided

Study ID Numbers: 199/11822, UCSD-1062
Study First Received: October 18, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004313     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
Addison's disease
endocrine disorders
rare disease
primary adrenal insufficiency

Study placed in the following topic categories:
Addison's Disease
Immunologic Factors
Adrenal Gland Diseases
Brain Diseases
Hypoadrenalism
X-linked Adrenoleukodystrophy
Metabolism, Inborn Errors
Heredodegenerative Disorders, Nervous System
Peroxisomal Disorders
Adrenoleukodystrophy
Addison Disease
Genetic Diseases, X-Linked
Brain Diseases, Metabolic, Inborn
Epinephrine
Metabolic Disorder
Neurobehavioral Manifestations
Adrenal Insufficiency
Autoimmune Diseases
Metabolic Diseases
Demyelinating Diseases
Adrenal Gland Hypofunction
Adjuvants, Immunologic
Rare Diseases
Dehydroepiandrosterone
Central Nervous System Diseases
Endocrine System Diseases
Mental Retardation
Genetic Diseases, Inborn
Neurologic Manifestations
Endocrinopathy

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Adrenal Gland Diseases
Brain Diseases
Hereditary Central Nervous System Demyelinating Diseases
Metabolism, Inborn Errors
Heredodegenerative Disorders, Nervous System
Peroxisomal Disorders
Adrenoleukodystrophy
Addison Disease
Genetic Diseases, X-Linked
Brain Diseases, Metabolic, Inborn
Neurobehavioral Manifestations
Adrenal Insufficiency
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Adjuvants, Immunologic
Central Nervous System Diseases
Endocrine System Diseases
Dehydroepiandrosterone
Pharmacologic Actions
Mental Retardation
Genetic Diseases, Inborn
Neurologic Manifestations
Mental Retardation, X-Linked
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on May 07, 2009