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

Information source: University Hospitals of Cleveland
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: BPH; Erectile Dysfunction

Intervention: Alfuzosin 10 mg (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospitals of Cleveland

Official(s) and/or principal investigator(s):
Allen D Seftel, MD, Principal Investigator, Affiliation: University Urologists of Cleveland

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluate the medication on erection maintenance

Secondary outcome: Assess effect of Uroxatral on BPH and sexual function using questionnaires

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.

Eligibility

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States; Recruiting
Ann M Serenko, MS, RN, Phone: 216-844-3515, Email: ann.serenko@uhhs.com
Allen D Seftel, MD, Phone: 216-844-7728, Email: adseftel@aol.com
Allen D Seftel, MD, Principal Investigator
Martin Resnick, MD, Sub-Investigator
Donald Bodner, MD, Sub-Investigator
Additional Information

Starting date: November 2005
Last updated: November 26, 2007

Page last updated: February 07, 2013

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