Trials / Completed
CompletedNCT00004313
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dehydroepiandrosterone |
Timeline
- Start date
- 1995-08-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004313. Inclusion in this directory is not an endorsement.