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

Addison's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004313
• Other study ID #: 199/11822
• Secondary ID: UCSD-1062
• Status: Completed
• Phase: Phase 3
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: August 1995

Study information

• Verified date: January 2000
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addison Disease
• Addison's Disease
• Adrenal Insufficiency

Intervention

Drug:
• dehydroepiandrosterone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of California, Los Angeles