Randomized, placebo-controlled, double-blind, parrallel design trial of the efficacy and safety of Zestra® in women with mixed desire / interest / arousal / orgasm disorders

Efficacy was determined with widely used instruments. Safety was determined by physical examinations, laboratory analyses, and adverse events. Eighty percent of efficacy variables showed more beneficial results for Zestra® than placebo. Zestra® improved desire, arousal and treatment satisfaction. Subjects who received Zestra® continued through the end of the study in greater numbers (84 %) than those who received placebo (59 %). The use of antidepressants had no impact on responsiveness. The only statistically significant adverse event was genital burning seen only in Zestra® treated subjects (15%).

The arousal and desire benefits from a previous trial, in highly selected subjects, was now confirmed in a population that mirrors the general population of women with sexual difficulties. The only statistically significant adverse event was the same one seen in the first study, and it occurred at the same frequency. No new adverse events emerged. The significant benefits in treatment satisfaction are new findings. This randomized, double-blind, placebo-controlled trial of Zestra® in women with mixed desire/interest/ arousal/orgasm disorders showed that Zestra® is well tolerated and provides significant desire, arousal, and treatment satisfaction benefits for a broad, generalized group of women with sexual difficulties.