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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004313
• Date of registration: 18/10/1999
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
• Date of first enrolment: August 1995
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004313
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: Samuel S. C. Yen
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Addison's Disease

Intervention(s)

Drug: dehydroepiandrosterone

Secondary ID(s)

199/11822

UCSD-1062

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Los Angeles