Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

NCT ID: NCT00256399

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-05-08

Brief Summary

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

Detailed Description

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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.

Conditions

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BPH Erectile Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Alfuzosin 10 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allen D Seftel, MD

Role: PRINCIPAL_INVESTIGATOR

University Urologists of Cleveland

Locations

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University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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L-9835

Identifier Type: -

Identifier Source: org_study_id

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