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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Open label safety and efficacy follow-up.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genelabs Technologies
• Treatments: Dehydroepiandrosterone; Glucocorticoids

Criteria

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