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.

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).

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: Alfuzosin

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Chesapeake Urology Research Associates
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
    • Glen Burnie, Maryland, United States, 21061
      • Chesapeake Urology Research Associates
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo, Then Alfuzosin; Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.	Drug: Placebo; Alfuzosin-matched One tablet once daily; Drug: Alfuzosin; 10 mg once daily
EXPERIMENTAL: Alfuzosin, Then Placebo; Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.	Drug: Placebo; Alfuzosin-matched One tablet once daily; Drug: Alfuzosin; 10 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chesapeake Urology Research Associates
• Collaborators: Sanofi
• Investigators: Principal Investigator: Ronald F Tutrone, MD, Chesapeake Urology Research Associates

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: April 8, 2009
• First Submitted That Met QC Criteria: May 4, 2009
• First Posted (ESTIMATE): May 5, 2009

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Urological Manifestations; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Lower Urinary Tract Symptoms; Erectile Dysfunction; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Alfuzosin
• Other Study ID Numbers: CURA-RT-002