Clinical Trial: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary:
OBJECTIVES:
I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).
Detailed Summary:
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.
Sponsor: National Center for Research Resources (NCRR)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Office of Rare Diseases (ORD)
Dates:
Date Received: October 18, 1999
Date Started: August 1995
Date Completion:
Last Updated: June 23, 2005
Last Verified: January 2000