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

Genelabs Technologies

Status and phase

Completed

Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Prasterone (GL701)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00082511

GL03-01

Details and patient eligibility

About

Open label safety and efficacy follow-up.

Full 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.

Enrollment

114 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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