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

Brief Title

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


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.
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Addison's Disease

Intervention

dehydroepiandrosterone


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

August 1995



Eligibility 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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Samuel S. C. Yen, , 



Administrative Informations


NCT ID

NCT00004313

Organization ID

199/11822

Secondary IDs

UCSD-1062


Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 University of California, Los Angeles

Study Sponsor

Samuel S. C. Yen, Study Chair, University of California, Los Angeles


Verification Date

January 2000