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PRILIGY Usage Patterns in Selected Populations

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cegedim Strategic Data
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01273545
First received: December 8, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction, Physiological
 Drug: PRILIGY (dapoxetine hydrochloride)
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: PRILIGY Usage Patterns in Selected Populations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population. [ Time Frame: For up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The number of patients prescribed PRILIGY who do not have a diagnosis suggestive of the approved indication. [ Time Frame: For up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Groups/Cohorts Assigned Interventions
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)
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273545

Sponsors and Collaborators
Janssen Research & Development, LLC
Cegedim Strategic Data
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01273545     History of Changes
Other Study ID Numbers: CR017668, R096769PRE4005
Study First Received: December 8, 2010
Last Updated: June 3, 2013
Health Authority: United States: None due to the nature of the study (Registry)

Keywords provided by Janssen Research & Development, LLC:
Dapoxetine hydrochloride (PRILIGY)
Premature ejaculation

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Sexual and Gender Disorders
 Mental Disorders
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013