Status:
COMPLETED
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
Premature ejaculation (PE) is a form of male sexual dysfunction. An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a multicenter, placebo-...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT00229073
Start Date
December 1 2004
End Date
October 1 2006
Last Update
June 8 2011
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