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

Launched by ALZA CORPORATION, DE, USA · Sep 15, 2005

Keywords

ClinConnect Summary

One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a randomized, double-blind study in men with PE. 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 dapoxetine at one of two dosages, or placebo, for use on an "as-needed" basis. The total duration of the study is approximately 14 weeks. ...

Gender

MALE

Eligibility 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.