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

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA

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

• 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