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

• Status: Completed
• Trial end date: 2006-06-01
• 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:

• Male citizens of Asian countries and Australia are encouraged to enroll in the study

• 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

• 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)