PRILIGY Usage Patterns in Selected Populations

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.

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Key information

Conditions

Sexual Dysfunction, Physiological Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Premature Ejaculation Sexual Dysfunctions, Psychological Urogenital Diseases

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population.

Time frame: For up to 1 year

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

Cegedim Strategic Data

Registry information

Important dates

Study start: 2010
Study completion: 2012
First posted: Jan 10, 2011
Registry last updated: Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed