PRILIGY Usage Patterns in Selected Populations

NCT01273545 | Completed

• 2 other identifiers: CR017668R096769PRE4005
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sexual Dysfunction, Physiological

Keywords

Dapoxetine hydrochloride (PRILIGY); Premature ejaculation

Outcome Measures

Primary Outcomes (1)

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

  For up to 1 year

Secondary Outcomes (3)

• 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 are at risk for bleeding due to current use of nonsteroidal anti-inflammatory drugs (NSAID's) and warfarin.

  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

Study Arms (1)

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

Drug: PRILIGY (dapoxetine hydrochloride)

Interventions

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

001

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients prescribed PRILIGY by physicians who contributed data to the CSD electronic health services databases for German urologists, German general practitioners, or Italian general practitioners.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Cegedim Strategic Data: collaborator

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Premature Ejaculation

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ejaculatory Dysfunction; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: January 10, 2011
• Study Start: January 1, 2010
• Study Completion: December 1, 2012
• Last Updated: April 8, 2014

Record last verified: 2014-04