drugset / Trial / NCT00457457

Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

NCT00457457

Phase 2 Completed 609 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.

Timeline

Start
2007-05
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject GISADENAFIL Small molecule 10 mg
Subject GISADENAFIL Small molecule 25 mg
Subject GISADENAFIL Small molecule 40 mg
Subject GISADENAFIL Small molecule 50 mg
Subject GISADENAFIL Small molecule 100 mg
Comparator Tamsulosin Other / unclassified 0.4 mg