Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004313
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the efficacy of dehydroepiandrosterone DHEA an androgen replacement hormone for patients with primary adrenal insufficiency Addisons disease
I Determine the efficacy of dehydroepiandrosterone DHEA an androgen replacement hormone for patients with primary adrenal insufficiency Addisons 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSD-1062 | None | None | None |