Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency

National Center for Research Resources (NCRR)0 sites40 target enrollmentAugust 1995

ConditionsAddison's Disease

Drugsdehydroepiandrosterone

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Addison's Disease
Sponsor: National Center for Research Resources (NCRR)
Enrollment: 40
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

OBJECTIVES:

I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

August 1995

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All