Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
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ClinicalTrials.gov Identifier: NCT00004313 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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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 |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | August 1995 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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)

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
Study Chair: | Samuel S. C. Yen | University of California, Los Angeles |
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 |
Addison's disease endocrine disorders rare disease primary adrenal insufficiency |
Adrenal Insufficiency Addison Disease Adrenal Gland Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |