Approval Probability
TA Base Rate
Adjusted LOA
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Dapoxetine · 5 trials · 4 indications
The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below.
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 | EXPERIMENTAL | Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours. |
| 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 |
|---|---|---|
| Dapoxetine | DRUG | Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours. |
| 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. |
| 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: * Participants must be heterosexual males and in a stable monogamous, sexual relationship with a female partner for at least 6 months * must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT) * Must have a self-estimated intravaginal ejaculatory latency time (IELT) of...
Dapoxetine is an investigational small molecule being studied for the treatment of premature ejaculation and erectile dysfunction. It is being developed by Johnson & Johnson (JNJ) and is currently in Phase 3 clinical trials. The drug is intended for use in adult males aged 18 years and older.
Dapoxetine is a small molecule being developed for sexual dysfunction. Its specific molecular target has not been disclosed in the available information. The drug is being studied for its effectiveness and safety in treating premature ejaculation and erectile dysfunction in men.
Dapoxetine is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and effectiveness in treating premature ejaculation and erectile dysfunction.
Dapoxetine is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 2,678 participants. All trials were randomized, double-blind, and placebo-controlled.
Dapoxetine has completed three Phase 3 clinical trials: NCT00210613, NCT00210704, and NCT00229073. These trials studied the drug's effectiveness and safety in treating premature ejaculation and erectile dysfunction. A fourth trial, NCT01063855, examined concomitant use of PriLigy in men treated for erectile dysfunction.
Yes, Dapoxetine is also known as PriLigy. A clinical trial (NCT01063855) investigated the concomitant use of PriLigy in men treated for erectile dysfunction. This trial was completed and enrolled 495 participants across multiple countries including the United States, Argentina, Australia, and Canada.