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Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer

NCT00598312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2010-09-08

No results posted yet for this study

Summary

The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.

Conditions

Interventions

DRUG

Leuprolide Acetate for Injectable Suspension

Sustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product

Sponsors & Collaborators

  • Oakwood Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Daniel Saltzstein, MD · Urology San Antonio Research PA

  • James Page, MD · Oakwood Laboratories, LLC

  • Beth Glasgow · Oakwood Laboratories, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00598312 on ClinicalTrials.gov