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

Open label safety and efficacy follow-up.

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.

Inclusion Criteria:

• Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.
• Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
• Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.

Exclusion Criteria:

• Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
• Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).

MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY

• Calcitonin
• Bisphosphonates
• Fluoride at pharmacologic dose
• Strontium at pharmacologic dose
• Estrogenic steroids (except oral contraceptives)
• Selective Estrogen Receptor Modulator (raloxifene)
• Parathyroid hormone
• Any androgens, including prescription or nutritional supplement DHEA, other than study drug
• Additional Calcium supplements other than those prescribed as part of this study