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| ID | Type | Description | Link |
|---|---|---|---|
| C-2002-014 |
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The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.
This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapoxetine | Drug | 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events reported | Up to 9 months | |
| Results from physical examinations | Months 3 and 9 or termination visit | |
| Results from vital signs measurements | Months 1, 2 and 6 | |
| Results from clinical laboratory tests | Months 1, 3, and 9 or termination visit | |
| Results from ECGs | At the 3 month visit and the 9 month visit/Termination Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Results from patient reported outcomes (PRO) for perception of sexual functioning | During use of dapoxetine for up to 9 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alza Corporation Clinical Trial | ALZA | Study Director |
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| Label | URL |
|---|---|
| An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation. | View source |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D061686 | Premature Ejaculation |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C080598 | dapoxetine |
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| D001523 | Mental Disorders |
| D000097910 | Ejaculatory Dysfunction |
| D012725 | Sexual Behavior |
| D001519 | Behavior |