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A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220194
First Posted: September 22, 2005
Last Update Posted: October 14, 2016
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.
Information provided by:
San Bernardino Urological Associates Medical Group Inc
  Purpose
Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone levels are measured at set intervals to determine if Eligard is equal or better then Lupron or Zoladex in advanced Prostate Cancer patients.

Condition Intervention Phase
Cancer of Prostate Drug: leuprolide acetate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by San Bernardino Urological Associates Medical Group Inc:

Estimated Enrollment: 100
Study Start Date: April 2003
Estimated Study Completion Date: June 2005
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria: Patient with Advanced Ca, on stable dose of Lupron or Zoladex

Exclusion Criteria:

  • Previous exposure to Eligard.
  Contacts and Locations
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): NCT00220194


Locations
United States, California
San bernardino Urological Associates Medical Group
San Bernardino, California, United States, 92404
Sponsors and Collaborators
San Bernardino Urological Associates Medical Group Inc
Investigators
Principal Investigator: Franklin M Chu, MD San Bernfardino Urological Associates
  More Information

ClinicalTrials.gov Identifier: NCT00220194     History of Changes
Other Study ID Numbers: SBU001
Sanofi Aventis
First Submitted: September 17, 2005
First Posted: September 22, 2005
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Goserelin
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents


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