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| ID | Type | Description | Link |
|---|---|---|---|
| R096769PRE4005 | Other Identifier | Janssen Research & Development, LLC |
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| Name | Class |
|---|---|
| Cegedim Strategic Data | INDUSTRY |
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This study will use electronic health services databases to describe the usage patterns of dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the extent and proportion of patients with characteristics suggestive of the use of PRILIGY within, versus outside of the intended use population.
This study will use anonymized (nameless) patient data from electronic health services databases in Germany and Italy to describe the proportion of PRILIGY (dapoxetine hydrochloride) usage among those patients with characteristics suggestive of the use of PRILIGY within versus outside (eg, those with contraindications) of the intended use (IU) population. This is an observational study; no investigational drug will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | PRILIGY (dapoxetine hydrochloride) The study will observe characteristics of the patients to whom PRILIGY 30-mg and 60-mg tablets are prescribed in Germany by general practitioners and (separately) by urologists and in Italy by urologists |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRILIGY (dapoxetine hydrochloride) | Drug | The study will observe characteristics of the patients to whom PRILIGY 30-mg and 60-mg tablets are prescribed in Germany by general practitioners and (separately) by urologists, and in Italy by urologists |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population. | For up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients prescribed PRILIGY who have conditions or use medications that are described in the special warnings and precautions section of the PRILIGY Summary of Product Characteristics (SPC) | For up to 1 year | |
| The number of patients prescribed PRILIGY who are at risk for bleeding due to current use of nonsteroidal anti-inflammatory drugs (NSAID's) and warfarin. |
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Inclusion Criteria:
Exclusion Criteria:
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Male patients prescribed PRILIGY by physicians who contributed data to the CSD electronic health services databases for German urologists, German general practitioners, or Italian general practitioners.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC C. Clinical Trial | Janssen Research & Development, LLC | Study Director |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| C080598 | dapoxetine |
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| For up to 1 year |
| The number of patients prescribed PRILIGY who do not have a diagnosis suggestive of the approved indication. | For up to 1 year |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |