Presentation Authors: Filippo Migliorini, Anna Marcer*, Paolo Bettica, Luigi Ziviani, Jesper Lund, Itali Poggesi, Walter Artibani, Stefano Milleri, Verona, Italy
Introduction: To assess the efficacy of a single oral dose of 5HT1A antagonist GSK958108 on ejaculation latency time (ELT) in male subjects suffering from premature ejaculation (PE).
Methods: A total of 35 male subjects were enrolled in a Phase 1 double-blind, placebo-controlled, parallel group masturbation-model study. All 35 subjects completed the study. No subject was withdrawn from the study. There were no major protocol deviations reported during the study.
Results: In the 3 mg GSK958108 treatment group, the ELT was estimated to be 16% longer (95% CI: -16% to +61%) than if the subjects had taken placebo. In the 7 mg GSK958108 treatment group, the ELT was estimated to be 77% longer (95% CI: +28% to +144%) than in the placebo group. The systemic exposure to GSK958108 increased with dosage between 3 mg and 7 mg. A significant trend toward an increase of ELT was observed with increasing plasma concentrations of GSK958108. Headache was the most common adverse effect, reported by seven subjects (20%). There were no serious adverse events or deaths reported during the study.
Conclusions: This study indicates that 5HT1A antagonist GSK958108 3 mg day and 7 mg day was found to be well-tolerated, safe and effective for the treatment of PE subjects and demonstrated a strong association between 5HT1A receptors and ejaculation control in humans (NCT00861484)
Source of Funding: GlaxoSmithKline