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Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)

NCT01078545 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 729

Last updated 2012-01-16

Study results available
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Summary

The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.

Conditions

Interventions

DRUG

Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine.

Sponsors & Collaborators

  • Fraktal.com.pl

    collaborator UNKNOWN

  • Med-net.pl

    collaborator UNKNOWN

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Jozef Haczynski, MD, PhD · Abbott Laboratories, Poland

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01078545 on ClinicalTrials.gov