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Primary objective:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Alfuzosin for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfuzosin | Drug | One tablet of 10mg once daily at the end of evening meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| MSHQ Ejaculation score | End of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MSHQ Ejaculation score | After 4 weeks of treatment | |
| MSHQ Ejaculation score | After 12 weeks of treatment | |
| Acute Urinary Retention |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Natesumroeng Taweeporn | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Bangkok | Thailand |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C047638 | alfuzosin |
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| End of treatment |
| Correlation between MSHQ and IPSS | End of treatment |
| I-PSS total score | After 1 week of treatment |
| I-PSS total score | After 4 weeks of treatment |
| I-PSS total score | After 12 weeks of treatment |
| I-PSS total score | End of treatment |
| IPSS total score decrease = 3 points | End of treatment |
| IPSS: filling sub-score | After 1 week of treatment |
| IPSS: filling sub-score | After 4 weeks of treatment |
| IPSS: filling sub-score | After 12 weeks of treatment |
| IPSS: filling sub-score | End of treatment |
| IPSS: nocturia symptoms sub-score | After 1 week of treatment |
| IPSS: nocturia symptoms sub-score | After 4 weeks of treatment |
| IPSS: nocturia symptoms sub-score | After 12 weeks of treatment |
| IPSS: nocturia symptoms sub-score | End of treatment |
| IPSS: voiding sub-score | After 1 week of treatment |
| IPSS: voiding sub-score | After 4 weeks of treatment |
| IPSS: voiding sub-score | After 12 weeks of treatment |
| IPSS: voiding sub-score | End of treatment |
| MSHQ ejaculation: erection sub-score | After 4 weeks of treatment |
| MSHQ ejaculation: erection sub-score | After 12 weeks of treatment |
| MSHQ ejaculation: erection sub-score | End of treatment |
| MSHQ ejaculation: satisfaction sub-score | After 4 weeks of treatment |
| MSHQ ejaculation: satisfaction sub-score | After 12 weeks of treatment |
| MSHQ ejaculation: satisfaction sub-score | End of treatment |
| Quality of Life | After 4 weeks of treatment |
| Quality of Life | After 12 weeks of treatment |
| Quality of Life | End of treatment |
| D052801 |
| Male Urogenital Diseases |