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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01063855 | Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction | PHASE3 | COMPLETED | 495 | — | — | Apr 1, 2010 | Sep 1, 2011 | Jan 24, 2013 | 69 | United States, Argentina +11 |
| NCT00210704 | A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation | PHASE3 | COMPLETED | 1,067 | — | — | Mar 1, 2005 | Jun 1, 2006 | Jun 8, 2011 | - | — |
| NCT00229073 | A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation | PHASE3 | COMPLETED | 1,116 | — | — | Dec 1, 2004 | Oct 1, 2006 | Jun 8, 2011 | - | — |
The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.
| Arm | Type | Description |
|---|---|---|
| Dapoxetine + PDE5I | EXPERIMENTAL | Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. |
| Placebo + PDE5I | PLACEBO_COMPARATOR | Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks. |
| Dapoxetine | DRUG | 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks. |
| PDE5I (phosphodiesterase-5 inhibitor) | DRUG | Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study. |
Inclusion Criteria: * Clinical diagnosis of erectile dysfunction (ED), International Index of Erectile Function (IIEF) score \>=21 at screening and baseline, and receiving treatment with a stable regimen of a phosphodiesterase 5 (PDE 5) inhibitor (ie, sildenafil, vardenafil, or tadalafil) for the t...