Trial Outcomes & Findings for An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms (NCT NCT00893113)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

74 participants

Primary outcome timeframe

Baseline and 12 Weeks

Results posted on

2018-03-09

Participant Flow

Private Urology Practice, recruited patients from June 2009 through May 2012

Prior or current therapies of Alpha Blocker or PDE 5 inhibitor 2 weeks prior to randomization or investigational agents 30 days prior to randomization excluded them. 11 participants screen failed.

Participant milestones

Participant milestones
Measure	Placebo, Then Alfuzosin Placebo: one tablet daily first, then 10 mg Alfuzosin daily	Alfuzosin, Then Placebo Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
Overall Study STARTED	36	38
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	13	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Then Alfuzosin Placebo: one tablet daily first, then 10 mg Alfuzosin daily	Alfuzosin, Then Placebo Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
Overall Study Lost to Follow-up	4	8
Overall Study Early Termination	1	1
Overall Study Withdrew Consent	8	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo, Then Alfuzosin n=36 Participants Placebo: one tablet daily first, then 10 mg Alfuzosin daily	Alfuzosin, Then Placebo n=38 Participants Alfuzosin: 10 mg once daily first, then one Placebo tablet daily	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=93 Participants	37 Participants n=4 Participants	72 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	55 years n=93 Participants	53 years n=4 Participants	54 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	38 Participants n=4 Participants	74 Participants n=27 Participants
Region of Enrollment United States	36 participants n=93 Participants	38 participants n=4 Participants	74 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

Population: The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.

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.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.	Alfuzosin n=22 Participants Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
Change From Baseline Erectile Function Domain of the International Index of Erectile Function	2.84 Change in EF Domain Score from Baseline Standard Deviation 7.492	2.84 Change in EF Domain Score from Baseline Standard Deviation 8.704

SECONDARY outcome

Timeframe: Baseline and 12 Weeks

Population: The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.

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).

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.	Alfuzosin n=22 Participants Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
Changes in American Urological Association (AUA) Symptom Index	-.1333 Change in AUA Score From Baseline Standard Deviation 4.984	.4222 Change in AUA Score From Baseline Standard Deviation 5.345

SECONDARY outcome

Timeframe: Baseline and 12 Weeks

Population: The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.

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).

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.	Alfuzosin n=22 Participants Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
Change in Total International Index of Erectile Function (IIEF) Score	4.644 Change in Total IIEF Score from Baseline Standard Deviation 14.872	6.24 Change in Total IIEF Score from Baseline Standard Deviation 15.876

Adverse Events

Placebo, Then Alfuzosin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Alfuzosin, Then Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo, Then Alfuzosin n=36 participants at risk Placebo: one tablet daily first, then 10 mg Alfuzosin daily	Alfuzosin, Then Placebo n=38 participants at risk Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
Metabolism and nutrition disorders Syncope	2.8% 1/36 • Number of events 1 • Every 12 weeks for each intervention. Adverse Events (AEs) were assessed at each visit by interviewing the patient. The Investigator assessed each AE and the relationship to the drug. AEs were only recorded if they were not listed on the label of Alfuzosin as a potential side effect.	0.00% 0/38 • Every 12 weeks for each intervention. Adverse Events (AEs) were assessed at each visit by interviewing the patient. The Investigator assessed each AE and the relationship to the drug. AEs were only recorded if they were not listed on the label of Alfuzosin as a potential side effect.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/36 • Every 12 weeks for each intervention. Adverse Events (AEs) were assessed at each visit by interviewing the patient. The Investigator assessed each AE and the relationship to the drug. AEs were only recorded if they were not listed on the label of Alfuzosin as a potential side effect.	2.6% 1/38 • Number of events 1 • Every 12 weeks for each intervention. Adverse Events (AEs) were assessed at each visit by interviewing the patient. The Investigator assessed each AE and the relationship to the drug. AEs were only recorded if they were not listed on the label of Alfuzosin as a potential side effect.

Other adverse events

Adverse event data not reported

Additional Information

Ronald Tutrone, MD

Chesapeake Urology Research Associates

Phone: 443.471.5742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place