Clinical Trial: PRILIGY Usage Patterns in Selected Populations

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: PRILIGY Usage Patterns in Selected Populations

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population. [ Time Frame: For up to 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) [ Time Frame: 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. [ Time Frame: For up to 1 year ]
  • The number of patients prescribed PRILIGY who do not have a diagnosis suggestive of the approved indication. [ Time Frame: For up to 1 year ]


Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: December 8, 2010
Date Started: January 2010
Date Completion:
Last Updated: April 7, 2014
Last Verified: April 2014