An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

Phase 3

Completed

Brief Summary: The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

Detailed Description: This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Recruitment & Eligibility

Inclusion Criteria

Male, 30-69 years of age
Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF
AUA score of less than or equal to 14
Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria

Blood pressure < 90/50 or > 170/110
Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
Diabetes Mellitus
History of PSA > 10
History of confirmed or suspected prostate cancer
History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN
On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
Receive treatment with other investigational agents within 30 days prior to enrollment

Arm && Interventions

Group	Intervention	Description
Placebo, Then Alfuzosin	Placebo	Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.
Alfuzosin, Then Placebo	Placebo	Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.
Placebo, Then Alfuzosin	Alfuzosin	Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks.
Alfuzosin, Then Placebo	Alfuzosin	Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline Erectile Function Domain of the International Index of Erectile Function	Baseline and 12 Weeks	The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.

Secondary Outcome Measures

Name	Time	Method
Changes in American Urological Association (AUA) Symptom Index	Baseline and 12 Weeks	The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).
Change in Total International Index of Erectile Function (IIEF) Score	Baseline and 12 Weeks	The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).

Locations (1): Chesapeake Urology Research Associates
🇺🇸
Towson, Maryland, United States