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

• Sponsor: Chesapeake Urology Research Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT00893113
• Collaborator: Sanofi (Industry)
• Enrollment: 74
• Locations: 4
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 18.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction; Lower Urinary Tract Symptoms	Drug: Placebo; Drug: Alfuzosin	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Double Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men With ED and Mild LUTS.
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo, Then 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.	Drug: Placebo; Alfuzosin-matched One tablet once daily; Drug: Alfuzosin; 10 mg once daily
Experimental: Alfuzosin, Then 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.	Drug: Placebo; Alfuzosin-matched One tablet once daily; Drug: Alfuzosin; 10 mg once daily

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 69 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chesapeake Urology Research Associates	Baltimore	Maryland	United States	21204
2	Chesapeake Urology Research Associates	Baltimore	Maryland	United States	21237
3	Chesapeake Urology Research Associates	Glen Burnie	Maryland	United States	21061
4	Chesapeake Urology Research Associates	Towson	Maryland	United States	21204

Sponsors and Collaborators

• Chesapeake Urology Research Associates
• Sanofi

Investigators

• Principal Investigator: Ronald F Tutrone, MD, Chesapeake Urology Research Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chesapeake Urology Research Associates
• ClinicalTrials.gov Identifier: NCT00893113
• Other Study ID Numbers: CURA-RT-002
• First Posted: May 5, 2009
• Last Update Posted: Mar 9, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Erectile Dysfunction; Lower Urinary Tract Symptoms; Alfuzosin

Study Results

Participant Flow

Recruitment Details	Private Urology Practice, recruited patients from June 2009 through May 2012
Pre-assignment Detail	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.

Arm/Group Title	Placebo, Then Alfuzosin	Alfuzosin, Then Placebo
Arm/Group Description	Placebo: one tablet daily first, then 10 mg Alfuzosin daily	Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
Period Title: Overall Study
STARTED	36	38
COMPLETED	23	22
NOT COMPLETED	13	16

Baseline Characteristics

Arm/Group Title	Placebo, Then Alfuzosin	Alfuzosin, Then Placebo	Total
Arm/Group Description	Placebo: one tablet daily first, then 10 mg Alfuzosin daily	Alfuzosin: 10 mg once daily first, then one Placebo tablet daily	Total of all reporting groups
Overall Participants	36	38	74
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 97.2%	37 97.4%	72 97.3%
>=65 years	1 2.8%	1 2.6%	2 2.7%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55	53	54
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	36 100%	38 100%	74 100%
Region of Enrollment (participants) [Number]
United States	36 100%	38 100%	74 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Erectile Function Domain of the International Index of Erectile Function
Description	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.
Time Frame	Baseline and 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Alfuzosin
Arm/Group Description	Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.	Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
Measure Participants	23	22
Mean (Standard Deviation) [Change in EF Domain Score from Baseline]	2.84 (7.492)	2.84 (8.704)

2. Secondary Outcome

Title	Changes in American Urological Association (AUA) Symptom Index
Description	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).
Time Frame	Baseline and 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Alfuzosin
Arm/Group Description	Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.	Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
Measure Participants	23	22
Mean (Standard Deviation) [Change in AUA Score From Baseline]	-.1333 (4.984)	.4222 (5.345)

3. Secondary Outcome

Title	Change in Total International Index of Erectile Function (IIEF) Score
Description	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).
Time Frame	Baseline and 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Alfuzosin
Arm/Group Description	Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.	Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
Measure Participants	23	22
Mean (Standard Deviation) [Change in Total IIEF Score from Baseline]	4.644 (14.872)	6.24 (15.876)

Adverse Events

Time Frame	Every 12 weeks for each intervention.
Adverse Event Reporting Description	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.
Arm/Group Title	Placebo, Then Alfuzosin		Alfuzosin, Then Placebo
Arm/Group Description	Placebo: one tablet daily first, then 10 mg Alfuzosin daily		Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
All Cause Mortality
	Placebo, Then Alfuzosin		Alfuzosin, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo, Then Alfuzosin		Alfuzosin, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)		1/38 (2.6%)
Metabolism and nutrition disorders
Syncope	1/36 (2.8%)	1	0/38 (0%)	0
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	0/36 (0%)	0	1/38 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Placebo, Then Alfuzosin		Alfuzosin, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/38 (0%)

Limitations/Caveats

Data compiled in this study is unable to neither prove nor disprove the objectives set. Placebo effect and recall bias may affect results. Regular sexual interaction and prior exposure to Alfuzosin were not evaluated.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.