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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier:
NCT00893113
First received: April 8, 2009
Last updated: June 22, 2016
Last verified: June 2016
  Purpose
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).

Condition Intervention Phase
Erectile Dysfunction
Lower Urinary Tract Symptoms
Drug: Placebo
Drug: Alfuzosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chesapeake Urology Research Associates:

Primary Outcome Measures:
  • Change From Baseline Erectile Function Domain of the International Index of Erectile Function [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 74
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893113

Locations
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21204
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States, 21061
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Chesapeake Urology Research Associates
Sanofi
Investigators
Principal Investigator: Ronald F Tutrone, MD Chesapeake Urology Research Associates
  More Information

Responsible Party: Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier: NCT00893113     History of Changes
Other Study ID Numbers: CURA-RT-002 
Study First Received: April 8, 2009
Results First Received: March 24, 2015
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Lower Urinary Tract Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Urological Manifestations
Signs and Symptoms
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on August 24, 2016