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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:
Information provided by:
San Bernardino Urological Associates Medical Group Inc
ClinicalTrials.gov Identifier:
NCT00220194
First received: September 17, 2005
Last updated: October 19, 2005
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00220194     History of Changes
Other Study ID Numbers: SBU001, Sanofi Aventis
Study First Received: September 17, 2005
Last Updated: October 19, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Leuprolide
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 22, 2013