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| Sponsor: | Chesapeake Urology Research Associates |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by (Responsible Party): | 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 |
| 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. |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Alfuzosin
10 mg once daily
Drug: Alfuzosin
10 mg once daily
|
| Experimental: Alfuzosin |
Drug: Alfuzosin
10 mg once daily
|
Eligibility| Ages Eligible for Study: | 30 Years to 69 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Heather Thomas, CCRC, RT | 443-471-5741 | hthomas@cua.md |
| Contact: Virginia Michaels, CRC | 410-760-9400 ext 1616 | vmichaels@cua.md |
| United States, Maryland | |
| Chesapeake Urology Research Associates | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Valerie Nevins, CRC 443-471-5740 vnevins@cua.md | |
| Principal Investigator: Ronald F Tutrone, MD | |
| Sub-Investigator: David S Goldstein, MD | |
| Chesapeake Urology Research Associates | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Contact: Angela M Somers, CRC 410-391-6131 asomers@cua.md | |
| Sub-Investigator: William Dowling, MD | |
| Chesapeake Urology Research Associates | Recruiting |
| Glen Burnie, Maryland, United States, 21061 | |
| Contact: Virginia C Michaels, CCRC 443-471-5753 vmichaels@cua.md | |
| Sub-Investigator: Geoffrey N Sklar, MD | |
| Chesapeake Urology Research Associates | Recruiting |
| Towson, Maryland, United States, 21204 | |
| Contact: Debbie Robertson, CRC 410-825-6310 ext 163 drobertson@cua.md | |
| Sub-Investigator: Richard Levin, MD | |
| 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 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Alfuzosin Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
