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Clinical Trials/NCT00256399
NCT00256399CompletedNot Applicable

A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction

University Hospitals Cleveland Medical Center1 site in 1 country6 target enrollmentStarted: November 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
1
Primary Endpoint
Evaluate the medication on erection maintenance
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

Detailed Description

The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Males 45-75 years of age
  • •Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
  • •Men with steady partner and who agree to attempt sex once a week.

Exclusion Criteria

  • •Prostate cancer
  • •Prostatitis
  • •Penile disease
  • •Cardiac co-morbidity
  • •Pre-existing co-morbid conditions
  • •History of sensitivity to the drug or similar drugs
  • •Enrollment in another clinical trial
  • •Impaired hepatic function
  • •Impaired renal function
  • •Mental conditions rendering subject unable to understand the study
  • •Subjects not likely to comply with protocol

Outcomes

Primary Outcomes

Evaluate the medication on erection maintenance

Secondary Outcomes

  • Assess effect of Uroxatral on BPH and sexual function using questionnaires

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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