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NCT00220194 Clinical Trial

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

Cancer of Prostate Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00220194
Other study ID # SBU001
Secondary ID Sanofi Aventis
Status Completed
Phase Phase 4
First received September 17, 2005
Last updated October 13, 2016
Start date April 2003
Est. completion date June 2005

Study information
Verified date October 2016
Source San Bernardino Urological Associates Medical Group Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: Patient with Advanced Ca, on stable dose of Lupron or Zoladex

Exclusion Criteria:

- Previous exposure to Eligard.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• leuprolide acetate

Locations
Country Name City State
United States San bernardino Urological Associates Medical Group San Bernardino California

Sponsors (1)
Lead Sponsor Collaborator
San Bernardino Urological Associates Medical Group Inc

Country where clinical trial is conducted

United States, 

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