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

NCT00082511 ↗

Phase 3 Completed 114 enrolled Genelabs Technologies

RandomizedParallel-groupOpen-labelTreatment

Summary

Open label safety and efficacy follow-up.

Timeline

Start: 2003-07
Primary completion: 2005-08
Completion: 2005-08

Outcome

Mixed primary results

paper mean +/- SD, 0.003 +/- 0.035 vs -0.005 +/- 0.053 g/cm(2), respectively; p = 0.293 between groups PMID 18634158 ↗

paper dose-dependent increase in BMD at the L-spine at Month 18 between patients who received 200 versus 100 mg/day prasterone (p = 0.021). PMID 18634158 ↗

Publications

Sanchez-Guerrero J, Fragoso-Loyo HE, Neuwelt CM, Wallace DJ, Ginzler EM, Sherrer YR, McIlwain HH, Freeman PG, Aranow C, Petri MA, Deodhar AA, Blanton E, Manzi S, Kavanaugh A, Lisse JR, Ramsey-Goldman R, McKay JD, Kivitz AJ, Mease PJ, Winkler AE, Kahl LE, Lee AH, Furie RA, Strand CV, Lou L, Ahmed M, Quarles B, Schwartz KE. Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. J Rheumatol. 2008 Aug;35(8):1567-75. Epub 2008 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dehydroepiandrosterone	Other / unclassified	100 mg	—
Subject	Dehydroepiandrosterone	Other / unclassified	200 mg	—