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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893113
• Other study ID #: CURA-RT-002
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2009
• Last updated: February 9, 2018
• Start date: June 2009
• Est. completion date: October 2012

Study information

• Verified date: February 2018
• Source: Chesapeake Urology Research Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 69 Years

Eligibility

Inclusion Criteria:

• Male, 30-69 years of age

• Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF

• AUA score of less than or equal to 14

• Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria:

• Blood pressure < 90/50 or > 170/110

• Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)

• Diabetes Mellitus

• History of PSA > 10

• History of confirmed or suspected prostate cancer

• History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN

• On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization

• Receive treatment with other investigational agents within 30 days prior to enrollment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Lower Urinary Tract Symptoms

Intervention

Drug:
• Placebo
Alfuzosin-matched One tablet once daily
• Alfuzosin
10 mg once daily

Locations

Country	Name	City	State
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Chesapeake Urology Research Associates	Glen Burnie	Maryland
United States	Chesapeake Urology Research Associates	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Chesapeake Urology Research Associates	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Erectile Function Domain of the International Index of Erectile Function	The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.	Baseline and 12 Weeks
Secondary	Changes in American Urological Association (AUA) Symptom Index	The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).	Baseline and 12 Weeks
Secondary	Change in Total International Index of Erectile Function (IIEF) Score	The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).	Baseline and 12 Weeks