PRILIGY Usage Patterns in Selected Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 主要终点
- The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Received a prescription for PRILIGY
- •Treated by physicians who contributed data to the IMS Disease Analyzer database for Germany and Thales database for Italy
排除标准
- •Age not specified
- •Sex not specified as "male
- •" Fewer than 6 months (183 days) of history in the electronic health services databases before receiving the first prescription for PRILIGY (At least 6 months of history in the database is not required for the patients of the German urologists).
研究组 & 干预措施
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
干预措施: PRILIGY (dapoxetine hydrochloride) (Drug)
结局指标
主要结局
The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population.
时间窗: For up to 1 year
次要结局
- 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 do not have a diagnosis suggestive of the approved indication.(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.(For up to 1 year)