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Study of GL701 in Men With Systemic Lupus Erythematosus

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: NCT00037128
Recruitment Status : Unknown
Verified May 2004 by Genelabs Technologies.
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2002
Last Update Posted : June 24, 2005
Information provided by:
Genelabs Technologies

Brief Summary:
Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy of GL701 in male lupus patients.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : March 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Prasterone

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Patient must have a diagnosis of SLE > 6 months according to the 1989 revised ACR criteria. Patient must meet at least four of the eleven ACR criteria for systemic lupus
  • Patient must have a modified SLEDAI score > 3 at both screening and qualifying visits (Appendix A-2)
  • Patient must be treated for SLE with doses of prednisone < 30 mg/day (including those on NO glucocorticoid therapy) unchanged for > 6 weeks prior to study entry (including both screening and qualifying visits). Prednisone dose in patient's receiving alternate day therapy will be the mean daily prednisone dose
  • Patient treated with azathioprine, methotrexate, or hydrochloroquine must be on a stable dose with no change in dose for at least 6 weeks preceding the study
  • Patient must be able to read and speak English and willing to sign an informed consent in English

Exclusion Criteria

  • Patient with a history of prostate cancer
  • Patient with elevated Prostate Specific Antigen (PSA)
  • Patient diagnosed with liver disease, defined as AST or ALT > 3x the upper limit of normal
  • Patient ingesting body building/anabolic steroids within the last 6 months preceding the study
  • Patient with end stage renal disease or receiving hemodialysis treatment
  • Patient with serum creatinine > 2 mg/dl or creatinine clearance < 60 ml/min
  • Patient receiving treatment with ACTH within the 3 months preceding study entry
  • Patient receiving androgens, immunoglobulins, cyclophosphamide, cyclosporin A, or other immunosuppressive agents, except azathioprine, methotrexate, and hydrochloroquine within the last 3 months
  • Patient with known hypersensitivity to DHEA or the inactive ingredients used in the GL70l formulation (cornstarch, lactose, and magnesium stearate)
  • Patient who participated in any prior DHEA study or administration of DHEA within the past 3 months
  • Patient using any investigational agents within the longer of 30 days or 10 half-lives of the agent
  • Patient with 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)
  • Patient requires treatment/medication prohibited by protocol
  • Patient with any serious EKG abnormality as determined by the Investigator

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 identifier (NCT number): NCT00037128

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United States, California
Genelabs Technologies, Inc.
Redwood City, California, United States, 94063
Sponsors and Collaborators
Genelabs Technologies

Layout table for additonal information Identifier: NCT00037128    
Other Study ID Numbers: GL97-01
First Posted: May 17, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2004
Keywords provided by Genelabs Technologies:
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs