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

Sponsor

Alza Corporation, DE, USA (Industry)

Overall Status

Completed

CT.gov ID

NCT00211094

Collaborator

(none)

1,320

Enrollment

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ejaculation	Drug: Dapoxetine	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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