Trial record 2 of 136 for:    Lupus AND (woman OR women OR female)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082511
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : January 14, 2008
Information provided by:
Genelabs Technologies

May 11, 2004
July 16, 2004
January 14, 2008
July 2003
August 2005   (Final data collection date for primary outcome measure)
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. [ Time Frame: 12 months ]
Not Provided
Complete list of historical versions of study NCT00082511 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
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.

Not Provided
Sánchez-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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2005
August 2005   (Final data collection date for primary outcome measure)

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).


  • 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States
Not Provided
Not Provided
Kenneth E. Schwartz, MD, Genelabs Technologies, Inc.
Genelabs Technologies
Not Provided
Not Provided
Genelabs Technologies
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP