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:

• Heterosexual male in a stable, monogamous, sexual relationship with a female partner for at least 6 months

• onset of orgasm and ejaculation occurs with minimal sexual stimulation before or shortly after penetration and before the person wishes it

• premature ejaculation (PE) in the majority of intercourse experiences in the 6 months before study initiation

• intravaginal latency ejaculatory time (IELT) of <=2 minutes in at least 3 out of 4 events

• participants with partners of child-bearing potential must consent to use a medically acceptable method of contraception throughout the entire study

• participant's partner must have a negative pregnancy test at time of screening.

Exclusion Criteria:

• History of surgery or injury to the pelvis or spinal cord, chronic inflammation of the prostate or urethra

• taking medications that are contraindicated for participation in the study

• currently using other forms of therapy for treatment of PE (for example, behavioral therapy or medications applied locally)

• previously participated in a drug study involving dapoxetine or in another drug trial within the last month

• taken pimozide, astemizole, or monoamine oxidase inhibitors within 6 months of the start of the study.