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An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride

NCT01021670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10027

Last updated 2013-11-26

No results posted yet for this study

Summary

The purpose of the study is to collect information regarding the safety of dapoxetine hydrochloride when used in clinical practice to treat men with premature ejaculation. Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for the treatment of patients with premature ejaculation.

Conditions

  • Sexual Dysfunction, Physiological
  • Ejaculation

Interventions

DRUG

Dapoxetine hydrochloride

One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks

OTHER

Alternate care/non-dapoxetine hydrochloride treatment(s)

As prescribed or directed

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC C. Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Completion
2012-09-30

Countries

  • Austria
  • Finland
  • Germany
  • Portugal
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021670 on ClinicalTrials.gov