Overview

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
0
Participant gender:
Male
Summary
The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Criteria
Inclusion Criteria:

- Patient is in a stable, monogamous sexual relationship with the same woman for at
least 6 months and plans to maintain this relationship for the duration of the study

- diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study
initiation

- history of intravaginal ejaculatory latency time (IELT) of <2 minutes in at least 3
out of 4 events

- good general health

- patient's partner must have a negative urine pregnancy test at time of screening

Exclusion Criteria:

- Not taken dapoxetine or participated in another study investigating pharmacologic
treatment of PE within the last 3 months

- no history of any medical events that are associated with the development of PE

- not taken another investigational drug within 1 month, or used an experimental medical
device within 6 months, of study initiation

- no positive diagnosis of depressive or anxiety disorder, manic episode, panic
disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse
and dependence, schizophrenia, or other psychotic disorders

- no known allergy or hypersensitivity to selective serotonin reuptake inhibitors
(SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)