Trial · NCT00893113
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
NCT00893113, Phase 3, Completed, Chesapeake Urology Research Associates; results first posted 2016-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms. Trials, record NCT00893113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00893113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
- NCT number
- NCT00893113
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 74 participants, actual
- Lead sponsor
- Chesapeake Urology Research Associates
- Conditions
- Erectile Dysfunction, Lower Urinary Tract Symptoms
- Interventions
- Placebo, Alfuzosin
- First posted
- 2009-05-05
- Last updated
- 2018-03-09
- Results first posted
- 2016-08-01
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Erectile Function Domain of the International Index of Erectile Function | Baseline and 12 Weeks | 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. | Change in EF Domain Score from Baseline | MEAN |
| SECONDARY | Changes in American Urological Association (AUA) Symptom Index | Baseline and 12 Weeks | 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. | Change in AUA Score From Baseline | MEAN |
| SECONDARY | Change in Total International Index of Erectile Function (IIEF) Score | Baseline and 12 Weeks | 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. | Change in Total IIEF Score from Baseline | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Erectile Function Domain of the International Index of Erectile Function | Placebo | 2.84 | Standard Deviation 7.492 | Change in EF Domain Score from Baseline | |
| Change From Baseline Erectile Function Domain of the International Index of Erectile Function | Alfuzosin | 2.84 | Standard Deviation 8.704 | Change in EF Domain Score from Baseline | |
| Changes in American Urological Association (AUA) Symptom Index | Placebo | -.1333 | Standard Deviation 4.984 | Change in AUA Score From Baseline | |
| Changes in American Urological Association (AUA) Symptom Index | Alfuzosin | .4222 | Standard Deviation 5.345 | Change in AUA Score From Baseline | |
| Change in Total International Index of Erectile Function (IIEF) Score | Placebo | 4.644 | Standard Deviation 14.872 | Change in Total IIEF Score from Baseline | |
| Change in Total International Index of Erectile Function (IIEF) Score | Alfuzosin | 6.24 | Standard Deviation 15.876 | Change in Total IIEF Score from Baseline |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo, Then Alfuzosin | 36 | |
| Overall Study | STARTED | Alfuzosin, Then Placebo | 38 | |
| Overall Study | COMPLETED | Placebo, Then Alfuzosin | 23 | |
| Overall Study | COMPLETED | Alfuzosin, Then Placebo | 22 | |
| Overall Study | NOT COMPLETED | Placebo, Then Alfuzosin | 13 | |
| Overall Study | NOT COMPLETED | Alfuzosin, Then Placebo | 16 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Syncope | Metabolism and nutrition disorders | Placebo, Then Alfuzosin | 1 | 36 | 1 |
| serious | Syncope | Metabolism and nutrition disorders | Alfuzosin, Then Placebo | 0 | 38 | 0 |
| serious | Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Placebo, Then Alfuzosin | 0 | 36 | 0 |
| serious | Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Alfuzosin, Then Placebo | 1 | 38 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo, Then Alfuzosin | ||
| Total, all-cause mortality | Alfuzosin, Then Placebo | ||
| Total, other adverse events | Placebo, Then Alfuzosin | 0 | 36 |
| Total, other adverse events | Alfuzosin, Then Placebo | 0 | 38 |
| Total, serious adverse events | Placebo, Then Alfuzosin | 1 | 36 |
| Total, serious adverse events | Alfuzosin, Then Placebo | 1 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Placebo, Then Alfuzosin vs Alfuzosin, Then Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00893113
GET https://conductscience.org/api/trials/v1/NCT00893113/registered