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An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
This study is not yet open for participant recruitment.
Verified by Chesapeake Urology Research Associates, May 2009
First Received: April 8, 2009   Last Updated: May 4, 2009   History of Changes
Sponsors and Collaborators: Chesapeake Urology Research Associates
Sanofi-Aventis
Information provided by: Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier: NCT00893113
  Purpose

The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in Men that have lower urinary tract symptoms.


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

MedlinePlus related topics: Erectile Dysfunction
Drug Information available for: Alfuzosin hydrochloride Alfuzosin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
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.

Further study details as provided by Chesapeake Urology Research Associates:

Primary Outcome Measures:
  • Change from baseline EF domain of the IIEF [ Time Frame: Week 1, Week 12, Week 24, ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator Drug: Alfuzosin
10 mg once daily
Drug: Alfuzosin
10 mg once daily
Alfuzosin: Experimental Drug: Alfuzosin
10 mg once daily

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has mild to moderate erectile Dysfunction
  • Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria:

  • Diabetes Mellitus
  • Neurological Disorders
  • Confirmed or suspected Prostate Cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893113

Contacts
Contact: Mary O'Conor, CCRC 443-471-5740 moconor@cua.md
Contact: Virginia Michaels, CRC 410-760-9400 vmichaels@cua.md

Locations
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21204
Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States, 21061
Chesapeake Urology Research Associates
Bel Air, Maryland, United States, 21014
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Chesapeake Urology Research Associates
Sanofi-Aventis
Investigators
Principal Investigator: Ronald F Tutrone, MD Chesapeake Urology Research Associates
  More Information

No publications provided

Responsible Party: Chesapeake Urology Research Associates ( Ronald Tutrone, MD )
Study ID Numbers: CURA-RT-002
Study First Received: April 8, 2009
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00893113     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Neurotransmitter Agents
Alfuzosin
Sexual Dysfunction, Physiological
Adrenergic Agents
Mental Disorders
Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Sexual Dysfunction, Physiological
Alfuzosin
Mental Disorders
Therapeutic Uses
Adrenergic Antagonists
Erectile Dysfunction

ClinicalTrials.gov processed this record on May 07, 2009