Status:

COMPLETED

Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

Lead Sponsor:

Pfizer

Conditions:

Prostatic Hyperplasia

Eligibility:

MALE

40+ years

Phase:

PHASE2

Brief Summary

This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

Eligibility Criteria

Inclusion

  • Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
  • Clinical diagnosis of BPH
  • Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
  • Urodynamically defined bladder outlet obstruction

Exclusion

  • prostate cancer
  • Post-void residual urine volume \>200 ml
  • Documented UTI
  • History of relevant urological surgery

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2008

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT00408954

Start Date

March 1 2007

End Date

June 1 2008

Last Update

November 23 2010

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Pfizer Investigational Site

Brno, Czechia, 612 00

2

Pfizer Investigational Site

Hradec Králové, Czechia, 500 02

3

Pfizer Investigational Site

Olomouc, Czechia, 775 20

4

Pfizer Investigational Site

Ústí nad Labem, Czechia, 401 13