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
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)|
|Estimated Enrollment :||40 participants|
|Study Start Date :||August 1995|
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|