NCT00004313

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2000

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Addison's Disease

Keywords

Addison's diseaseendocrine disordersrare diseaseprimary adrenal insufficiency

Interventions

dehydroepiandrosteroneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Addison DiseaseEndocrine System DiseasesRare Diseases

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Adrenal InsufficiencyAdrenal Gland DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Samuel S. C. Yen

    University of California, Los Angeles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

August 1, 1995

Last Updated

June 24, 2005

Record last verified: 2000-01