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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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)