Status:
COMPLETED
A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Sexual Dysfunction
Ejaculation
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to assess the possible withdrawal effects after abruptly stopping daily therapy with dapoxetine compared with continuing daily therapy in men with premature ejacula...
Detailed Description
Premature ejaculation (PE) is a form of male sexual dysfunction. A measure of withdrawal effects associated with stopping therapy for PE is the Discontinuation-Emergent Signs and Symptoms (DESS), a se...
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
- experience PE in the majority of sexual intercourse events
- good general health at study initiation
- patient and partner willing to avoid situations or activities that may have an effect o their sexual activity (for example, avoid pregnancy, refrain from any preplanned surgery)
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 such as surgery, injury, infections, or neurological conditions that are associated with the development of PE
- not taken an 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 :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00210613
Start Date
November 1 2004
End Date
August 1 2005
Last Update
June 8 2011
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