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.

First Received: September 17, 2005 Last Updated: October 19, 2005 History of Changes

Sponsor:	San Bernardino Urological Associates Medical Group Inc
Information provided by:	San Bernardino Urological Associates Medical Group Inc
ClinicalTrials.gov Identifier:	NCT00220194

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Leuprolide Leuprolide acetate Oxymesterone Testosterone enanthate Testosterone undecanoate

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

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

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male
Hormones

Pharmacologic Actions
Neoplasms
Testosterone
Neoplasms by Site
Leuprolide
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 05, 2009