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COMPLETED Phase 3

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

NCT00082511 · View on ClinicalTrials.gov ↗

Study Summary

Open label safety and efficacy follow-up.

Interventions

  • DRUG Prasterone (GL701)

Study Locations (20)

California

  • Wallace Rheumatic Study Center — Los Angeles
  • Lifestyles Health Science Center — Rancho Mirage
  • University of California San Diego — San Diego
  • East Bay Rheumatology Group — San Leandro

Florida

  • Center for Rheumatology, Immunology and Arthritis — Fort Lauderdale
  • Rheumatology Associates of Central Florida — Orlando
  • Tampa Medical Group, P.A. — Tampa

New York

  • SUNY Downstate Medical Center — Brooklyn
  • North Shore University Hospital, Division of Rheumatology — Manhasset
  • Albert Einstein Medical School — The Bronx

Missouri

  • St. John's Medical Research Group — Springfield
  • Washington University School of Medicine — St Louis

Pennsylvania

  • Altoona Center for Clinical Research — Duncansville
  • University of Pittsburgh — Pittsburgh

Arizona

  • University of Arizona — Tucson

Illinois

  • Northwestern University — Chicago

Maryland

  • Johns Hopkins University — Baltimore

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2003-07
Est. Completion 2005-08
Phase Phase 3

Sponsor

Genelabs Technologies

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00082511

The ClinicalTrials.gov registry entry for NCT00082511 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genelabs Technologies, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention — of which Prasterone (GL701) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00082511 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00082511 about?

NCT00082511 is a clinical study titled "GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids". Open label safety and efficacy follow-up.

What is the current status of trial NCT00082511?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2003-07. Estimated completion is 2005-08.

What conditions does trial NCT00082511 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00082511?

The interventions under investigation include: Prasterone (GL701) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00082511?

This trial is sponsored by Genelabs Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00082511 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial