Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone,
for patients with primary adrenal insufficiency (Addison's disease).
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
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
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)
18 Years - N/A
Accepts Healthy Volunteers
Samuel S. C. Yen, ,
National Center for Research Resources (NCRR)
University of California, Los Angeles
Samuel S. C. Yen, Study Chair, University of California, Los Angeles