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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

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ClinicalTrials.gov Identifier: NCT00220194
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 14, 2016
Sponsor:
Information provided by:
San Bernardino Urological Associates Medical Group Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer of Prostate Drug: leuprolide acetate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : April 2003
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources





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.

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

ClinicalTrials.gov Identifier: NCT00220194     History of Changes
Other Study ID Numbers: SBU001
Sanofi Aventis
First Posted: September 22, 2005    Key Record Dates
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