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)
Sponsored by: University Hospitals of Cleveland
Official(s) and/or principal investigator(s):
Allen D Seftel, MD, Principal Investigator, Affiliation: University Urologists of Cleveland
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in
males with BPH and ED.
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
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.
Minimum age: 45 Years.
Maximum age: 75 Years.
- 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.
- Prostate cancer
- 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: firstname.lastname@example.org
Allen D Seftel, MD, Phone: 216-844-7728, Email: email@example.com
Allen D Seftel, MD, Principal Investigator
Martin Resnick, MD, Sub-Investigator
Donald Bodner, MD, Sub-Investigator
Starting date: November 2005
Last updated: November 26, 2007