PRILIGY Usage Patterns in Selected Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sexual Dysfunction, Physiological

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

PRILIGY (dapoxetine hydrochloride)

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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).

Eligible Sex

MALE

Accepts Healthy Volunteers

No