Erectile Dysfunction, Lower Urinary Tract Symptoms
Conditions
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.
Interventions
DRUGPlacebo
Alfuzosin-matched One tablet once daily
DRUGAlfuzosin
10 mg once daily
Sponsors
Sanofi
Chesapeake Urology Research Associates
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
Private Urology Practice, recruited patients from June 2009 through May 2012
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo, Then Alfuzosin Placebo: one tablet daily first, then 10 mg Alfuzosin daily | 36 |
| Alfuzosin, Then Placebo Alfuzosin: 10 mg once daily first, then one Placebo tablet daily | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Early Termination | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 8 |
| Overall Study | Withdrew Consent | 8 | 7 |
Baseline characteristics
| Characteristic | Alfuzosin, Then Placebo | Placebo, Then Alfuzosin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 35 Participants | 72 Participants |
| Age, Continuous | 53 years | 55 years | 54 years |
| Region of Enrollment United States | 38 participants | 36 participants | 74 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 38 Participants | 36 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 38 |
| serious Total, serious adverse events | 1 / 36 | 1 / 38 |
Outcome results
Primary
Change From Baseline Erectile Function Domain of the International Index of Erectile Function
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Alfuzosin | Change From Baseline Erectile Function Domain of the International Index of Erectile Function | 2.84 Change in EF Domain Score from Baseline | Standard Deviation 8.704 |
Secondary
Change in Total International Index of Erectile Function (IIEF) Score
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total International Index of Erectile Function (IIEF) Score | 4.644 Change in Total IIEF Score from Baseline | Standard Deviation 14.872 |
| Alfuzosin | Change in Total International Index of Erectile Function (IIEF) Score | 6.24 Change in Total IIEF Score from Baseline | Standard Deviation 15.876 |
Secondary
Changes in American Urological Association (AUA) Symptom Index
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Changes in American Urological Association (AUA) Symptom Index | -.1333 Change in AUA Score From Baseline | Standard Deviation 4.984 |
| Alfuzosin | Changes in American Urological Association (AUA) Symptom Index | .4222 Change in AUA Score From Baseline | Standard Deviation 5.345 |