PRILIGY Usage Patterns in Selected Populations

Completed

• Conditions: Sexual Dysfunction, Physiological
• Interventions: Drug: PRILIGY (dapoxetine hydrochloride)

• Registration Number: NCT01273545
• Lead Sponsor: Janssen Research & Development, LLC

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 Description

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Study Completion: 2012-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3000

Inclusion Criteria

• Received a prescription for PRILIGY
• Treated by physicians who contributed data to the IMS Disease Analyzer database for Germany and Thales database for Italy

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	PRILIGY (dapoxetine hydrochloride)	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

Primary Outcome Measures

Name	Time	Method
The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population.	For up to 1 year

Secondary Outcome Measures

Name	Time	Method
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