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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Brief Summary

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OBJECTIVES:

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

Detailed Description

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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.

Conditions

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Addison's Disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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dehydroepiandrosterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Samuel S. C. Yen

Role: STUDY_CHAIR

University of California, Los Angeles

Other Identifiers

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UCSD-1062

Identifier Type: -

Identifier Source: secondary_id

199/11822