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NCT Number: NCT00893113

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

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).

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

30 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Chesapeake Urology Research Associates, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Alfuzosin-matched One tablet once daily

Alfuzosin

Drug

10 mg once daily

Primary outcomes

  1. Change From Baseline Erectile Function Domain of the International Index of Erectile Function

    Time frame: Baseline and 12 Weeks

    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 outcomes

  1. Changes in American Urological Association (AUA) Symptom Index

    Time frame: Baseline and 12 Weeks

    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).

  2. Change in Total International Index of Erectile Function (IIEF) Score

    Time frame: Baseline and 12 Weeks

    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).

Sponsors and collaborators

Lead sponsor

Chesapeake Urology Research Associates

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 5, 2009
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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