Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00914277 | SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction | PHASE2 | COMPLETED | 24 | — | — | May 1, 2009 | Oct 1, 2009 | May 2, 2011 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Period 1: placebo Period 2: sildenafil Period 3: SAR407899 dose level 2 Period 4: SAR407899 dose level 1 |
| Sequence 2 | EXPERIMENTAL | Period 1: sildenafil Period 2: SAR407899 dose level 1 Period 3: placebo Period 4: SAR407899 dose level 2 |
| Sequence 3 | EXPERIMENTAL | Period 1: SAR407899 dose level 1 Period 2: SAR407899 dose level 2 Period 3: sildenafil Period 4: placebo |
| Sequence 4 | EXPERIMENTAL | Period 1: SAR407899 dose level 2 Period 2: placebo Period 3: SAR407899 dose level 1 Period 4: sildenafil |
| Name | Type | Description |
|---|---|---|
| SAR407899 | DRUG | Oral administration |
| Placebo | DRUG | Oral administration |
| Sildenafil | DRUG | Oral administration |
Inclusion Criteria: * male with mild to moderate erectile dysfunction for at least 6 months * written informed consent Exclusion Criteria: * diabetes mellitus * orthostatic hypotension * hypogonadal testosterone level The above information is not intended to contain all considerations relevant t...