Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082511
Status:
COMPLETED
Last Update Posted:
2008-01-14
First Post:
2004-05-11
Brief Title:
GL701 Prestara in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Sponsor:
Genelabs Technologies
Organization:
Genelabs Technologies
Study Overview
Official Title:
A Multi-Center Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 Prestara in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Open label safety and efficacy follow-up
Detailed Description:
This was a randomized multi-center open-label parallel-group trial of prasterone 200 or 100 mgday for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized placebo-controlled study NCT00053560 Bone Mineral Density assessments were performed at baseline and at months 6 and 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None