PRILIGY Usage Patterns in Selected Populations

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Sexual Dysfunction, Physiological

Treatments: Drug: PRILIGY (dapoxetine hydrochloride)

Study type: Observational

Funder types: Industry

Identifiers

NCT01273545

CR017668

R096769PRE4005 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 patients

Sex: Male

Volunteers: No Healthy Volunteers

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).

Trial design

3,000 participants in 1 patient group

001

Description:

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

Treatment:

Drug: PRILIGY (dapoxetine hydrochloride)