Clinical Trials Resource Center

New Medical Therapies™

Premature Ejaculation

Patient Medical Areas

August 3, 2009

Plethora and Sciele issued positive results from a phase III trial of PSD502 for the treatment of premature ejaculation. This multi-center, randomized, double blind, placebo-controlled study enrolled subjects across the US, Canada and Europe. Results showed that PSD502 produced statistically significant increases from baseline in all co-primary study endpoints. The intra-vaginal ejaculation latency time (IELT) was increased at least six-fold with PSD502 when compared to baseline (p<0.0001). There was a five-point difference between PSD502 and placebo in the IPE domains for ejaculatory control and sexual satisfaction (p<0.0001) and there was a 2.5-point difference between PSD502 and placebo in the IPE domain for Distress (p<0.0001). Partner satisfaction, a secondary endpoint, was also found to be significantly greater with PSD502 than placebo. The incidence of serious adverse events and overall side effects was similar between the PSD502 and placebo groups.

April 28, 2003

NexMed reported positive results from a pilot study investigating alprostadil/lidocaine/NexACT, a topical cream combination for the treatment of premature ejaculation (PE). The primary efficacy measure was ejaculatory latency time (ELT). Results showed that the ELT increased to more than 2 minutes in 53.5% of all subjects in the treatment group compared with only 12.5% subjects in the control group. The secondary efficacy endpoints included the degree of satisfaction of both subject and partner. Results showed that the sexual satisfaction of subjects and their partners in the treatment group, reached 72.1% and 67.4%, respectively. No satisfaction was reported from either subjects or their partners in the control group. The 3-month, multi-center, single-blind study enrolled 51 PE subjects with a mean age of 37.7 years and PE symptom duration of 4.5 years.

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