NCT00893113

An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Chesapeake Urology Research Associates · Academic / Other
• Sex: Male
• Age: 30 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

Detailed description

This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Conditions

• Erectile Dysfunction
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	Placebo	Alfuzosin-matched One tablet once daily
DRUG	Alfuzosin	10 mg once daily

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-05-05
• Last updated: 2018-03-09
• Results posted: 2016-08-01

Locations

4 sites across 1 country: United States