NCT00082511

GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Genelabs Technologies · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 mg/day 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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Prasterone (GL701)	There were 4 arms to the study: During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study.

Timeline

• Start date: 2003-07-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2004-07-16
• Last updated: 2008-01-14

Locations

22 sites across 2 countries: United States, Mexico