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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of California, Los Angeles |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004313 |
OBJECTIVES:
I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).
Condition | Intervention | Phase |
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Addison's Disease |
Drug: dehydroepiandrosterone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
Estimated Enrollment: | 40 |
Study Start Date: | August 1995 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
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 |
Addison's disease endocrine disorders rare disease primary adrenal insufficiency |
Addison's Disease DHEA (Dehydroepiandrosterone) Immunologic Factors Adrenal Gland Diseases Hypoadrenalism Brain Diseases 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 |
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 |