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SS-cream is a topical agent for treating premature ejaculation (PE) which is made with extracts from 9 natural products. We evaluated the efficacy of SS-cream in the treatment of PE. An open pilot study was performed in 186 patients with PE. The mean ejaculatory latency from intromission to ejaculation was 1.5 minutes. Sixty-four of the 186 patients (34.4%) were combined with mild erectile dysfunction in whom penile rigidity was not sufficient to be satisfied in sexual activity. Patients were instructed to apply 0.1 gm. of SS-cream on the glans penis 1 hour before sexual contact and to wash out the cream before sexual intromission. Patients were asked to complete a report form including ejaculatory latency, the degree of satisfaction in the sexual lives of both themselves and their partners, and any adverse effects after each application. One hundred and sixty-six out of 186 patients (89.2%) reported they were satisfied with the application of the SS-cream and the mean ejaculatory latency was significantly prolonged to 10.89 +/- 5.60 minutes. The mean ejaculatory latency was 9.85 +/- 3.58 minutes in 52 out of 64 patients (81.2%) with mild erectile dysfunction. There was no significant difference in the changes of ejaculatory latencies between patients with pure PE and patients with mild erectile dysfunction. Twenty patients (10.8%) claimed to have no changes of ejaculatory latencies after the application of SS-cream. Adverse effects were noted in 11 patients (5.9%), which were mild local irritation symptoms in 7 patients, and delayed ejaculation of more than 30 minutes in 4 patients, the symptoms subsided spontaneously within 4 hours. These results indicate SS-cream is effective in the treatment of PE and also PE combined with mild erectile dysfunction with a few side effects. Further studies on the action mechanisms of SS-cream and a double blind placebo-controlled trial are needed.