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

Study Overview
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Brief Summary
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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
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One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). The study consists of 2 phases: pre-randomization phase (a screening visit and a 2-week baseline period); 12-week double-blind treatment phase during which patients will receive one of 2 doses of dapoxetine or placebo for use on an as-needed basis. The total duration of the study is approximately 14 weeks. Assessments of effectiveness include the average intravaginal ejaculatory latency time (as measured by stopwatch) during sexual intercourse, during the treatment period; control over ejaculation, participant and partner satisfaction with sexual intercourse, participant overall impression of change and severity of symptoms, based on questions asked at monthly intervals through the treatment phase. Safety assessments include the incidence, severity, and type of adverse events during the study, ECGs, as well as laboratory tests. At the end of the baseline period, patients from selected study centers will undergo blood sampling and ECG monitoring before and after the first dose of study medication. The study hypothesis is that treatment for 12 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE. Oral tablets of dapoxetine (30 milligrams [mg] or 60mg) or placebo taken as needed during 12 weeks of treatment. No more than 1 dose within a 24-hour period.

Official Title
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A Placebo-Controlled, Double-blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

Conditions
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Ejaculation

Intervention / Treatment
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* Drug: Dapoxetine


Participation Criteria
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Eligibility Criteria
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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 history of premature ejaculation in the 6 months before study initiation not due to distress, interpersonal difficulty or medication withdrawal history of intravaginal ejaculatory latency time (IELT) of < = 2 minutes in at least 3 out of 4 events blood pressure < = 180/100 mmHg at screening and end of baseline patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol patient's partner must have a negative urine pregnancy test at time of screening Exclusion Criteria: Not taken dapoxetine in a previous investigational drug study not using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin) no history of any medical events that are associated with the development of PE not taken another investigational drug within 1 month no history of seizures or major psychiatric disorder such as depression or schizophrenia no alcohol abuse and dependence no known allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors (SSRIs) no partners with decreased interest in or painful intercourse or other forms of sexual dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dapoxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12) for both doses of dapoxetine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 12; incidence, severity, and type of adverse events throughout study; medication helpfulness |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dapoxetine, premature ejaculation, ejaculation, sexual dysfunction, orgasmic disorder, sexual intercourse