167 Efficacy and safety of on-demand use of 2 treatments designed for different etiologies of female sexual interest/arousal disorder: 3 randomized clinical trials

Abstract

In women, low sexual desire and/or sexual arousal may lead to sexual dissatisfaction and emotional distress, collectively defined as Female Sexual Interest/Arousal Disorder (FSIAD). Few pharmaceutical treatment options are currently available. To investigate the efficacy and safety of two novel, on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups (women with low sensitivity for sexual cues and women with dysfunctional over-activation of sexual inhibition), employing a personalized medicine approach, using an allocation formula, based on genetic, hormonal, and psychological variables, developed to predict drug efficacy in the subgroups. 497 women (aged 21 to 70) with FSIAD were randomized to one of twelve, 8-week treatment regimens in three double-blind, randomized, placebo-controlled dose-finding studies, conducted at 16 research sites in the US. Efficacy and safety of the following on-demand treatments was tested: placebo, testosterone (T;0.5mg), sildenafil (S;50mg), buspirone (B;10mg), and the combination therapies T0.25mg+S25mg, T0.25mg+S50mg, T0.5mg+S25mg, T0.5mg+S50mg, and T0.25mg+B5mg, T0.25mg+B10mg, T0.5mg+B5mg, T0.5mg+B10mg.