A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Male

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 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

• 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 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 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)