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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004313
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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Brief Summary:

OBJECTIVES:

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


Condition or disease Intervention/treatment Phase
Addison's Disease Drug: dehydroepiandrosterone Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Addison Disease
Drug Information available for: Prasterone

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004313


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of California, Los Angeles
Investigators
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Study Chair: Samuel S. C. Yen University of California, Los Angeles
More Information
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ClinicalTrials.gov Identifier: NCT00004313    
Other Study ID Numbers: 199/11822
UCSD-1062
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2000
Keywords provided by Office of Rare Diseases (ORD):
Addison's disease
endocrine disorders
rare disease
primary adrenal insufficiency
Additional relevant MeSH terms:
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Adrenal Insufficiency
Addison Disease
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs