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Pivotal data for the investigational treatment PSD502 for primary premature ejaculation
Date:5/31/2010

ited States.

Pivotal Study Details

Men selected from 70 centers in the United States, Canada and Europe with primary PE and an Intravaginal Ejaculatory Latency Time (IELT) of less than one minute were randomly placed in one of two groups, two-thirds in the PSD502 group and one-third in the placebo group. Participants were instructed to apply PSD502 or placebo to the glans penis five minutes before intercourse. Efficacy was assessed from changes in IELT and in the domains of the Index of Premature Ejaculation (IPE), a patient reported outcome questionnaire, over a period of three months.

The baseline IELT in both study groups was less than 0.6 minutes which increased 5.5 fold and 1.6 fold in the PSD502 and placebo groups, respectively (p<0.0001), resulting in a mean IELT of 3.3 minutes in the PSD502 group. There were greater improvements in all domain scores of the IPE in the PSD502 group compared to placebo resulting in 6.1, 5.3 and 2.6 point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains respectively (p<0.0001 for all).

In the PSD502 group, 6.1% of patients reported treatment-related adverse events versus 0.6% in the placebo group. There was one treatment-related adverse event greater than or equal to 3% (loss of erection; 3.1%). Almost 7 percent (6.7%) of partners reported adverse events compared to 1.7% in the placebo group. The most commonly reported adverse event in partners was vulvovaginal burning sensation (5%).

About Premature Ejaculation (PE)

For years, experts debated about the definition of premature ejaculation. In 2008, the International Society for Sexual Medicine presented an evidence-based definition of PE as agreed upon by a consensus of the world's leading sexual health experts: a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetr
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Contact: Dave Schemelia
dschemelia@healthstarpr.com
609-468-9325
HealthStar PR
Source:Eurekalert

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