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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.
 
ClinicalTrials.gov Identifier: NCT00082511
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : January 14, 2008
Sponsor:
Information provided by:
Genelabs Technologies

Study Description
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Brief Summary:
Open label safety and efficacy follow-up.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Prasterone (GL701) Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Steroids
Drug Information available for: Prasterone

Arms and Interventions
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082511


Locations
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Sponsors and Collaborators
Genelabs Technologies
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kenneth E. Schwartz, MD, Genelabs Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00082511    
Other Study ID Numbers: GL03-01
First Posted: July 16, 2004    Key Record Dates
Last Update Posted: January 14, 2008
Last Verified: January 2008
Keywords provided by Genelabs Technologies:
Lupus
Systemic Lupus Erythematosus
SLE
Bone Loss
DHEA
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs