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

January 10, 2008 updated by: Genelabs Technologies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14000
        • Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90048
        • Wallace Rheumatic Study Center
      • Rancho Mirage, California, United States, 92270
        • Lifestyles Health Science Center
      • San Diego, California, United States, 92093-0943
        • University of California San Diego
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Group
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Center for Rheumatology, Immunology and Arthritis
      • Orlando, Florida, United States, 32806-6264
        • Rheumatology Associates of Central Florida
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Missouri
      • Springfield, Missouri, United States, 65804
        • St. John's Medical Research Group
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Medical School
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital, Division of Rheumatology
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Oklahoma Center for Arthritis Therapy
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Sentara Medical Group DBA
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Rheumatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genelabs Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

May 11, 2004

First Submitted That Met QC Criteria

July 15, 2004

First Posted (Estimate)

July 16, 2004

Study Record Updates

Last Update Posted (Estimate)

January 14, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL03-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on Prasterone (GL701)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe