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