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

Primary Purpose

Erectile Dysfunction, Lower Urinary Tract Symptoms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Alfuzosin
Sponsored by
Chesapeake Urology Research Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo, Then Alfuzosin

Alfuzosin, Then Placebo

Arm Description

Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 8, 2009
Last Updated
February 9, 2018
Sponsor
Chesapeake Urology Research Associates
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00893113
Brief Title
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chesapeake Urology Research Associates
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo, Then Alfuzosin
Arm Type
Placebo Comparator
Arm Description
Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.
Arm Title
Alfuzosin, Then Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Alfuzosin-matched One tablet once daily
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Intervention Description
10 mg once daily
Primary Outcome Measure Information:
Title
Change From Baseline Erectile Function Domain of the International Index of Erectile Function
Description
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.
Time Frame
Baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
Changes in American Urological Association (AUA) Symptom Index
Description
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).
Time Frame
Baseline and 12 Weeks
Title
Change in Total International Index of Erectile Function (IIEF) Score
Description
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).
Time Frame
Baseline and 12 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald F Tutrone, MD
Organizational Affiliation
Chesapeake Urology Research Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States

12. IPD Sharing Statement

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

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