NCT00547625

Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

A Multicenter, Parallel-Arm, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Tadalafil Administered Once Daily to Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.

Conditions

• Prostatic Hyperplasia
• Prostate

Interventions

Type	Name	Description
DRUG	tadalafil	Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.
DRUG	placebo	Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Timeline

• Start date: 2004-10-01
• Completion: 2005-07-01
• First posted: 2007-10-22
• Last updated: 2007-10-22

Locations

1 site across 1 country: United States