BPH, Erectile Dysfunction
Conditions
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.
Interventions
DRUGAlfuzosin 10 mg
Sponsors
Sanofi
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the medication on erection maintenance | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess effect of Uroxatral on BPH and sexual function using questionnaires | — |
Countries
United States
Outcome results
None listed