Randomized, Placebo-Controlled, Double Blind, Crossover Design Trial of the Efficacy and Safety of Zestra for Women in Women With and Without Female Sexual Arousal Disorder DAVID M. FERGUSON A1, GITA S. SINGH A2, CHRISTOPHER P. STEIDLE A6, J. STEVEN ALEXANDER , MARY K. WEIHMILLER , MARTIN G. CROSBY A1 Consultant in Clinical Development Services, Grand Marais, Minnesota, USA A2 Northeast Indiana Research, Ft. Wayne, Indiana, USA A3 Northeast Indiana Research, Ft. Wayne, Indiana, USA A4 Northeast Indiana Research, Ft. Wayne, Indiana, USA A5 Northeast Indiana Research, Ft. Wayne, Indiana, USA A6 QualiLife Pharmaceuticals, Charleston, South Carolina, USA Abstract: Zestra for Women is a botanical feminine massage oil formulated to enhance female sexual pleasure and arousal when applied to the vulva. We conducted this randomized, double-blinded, crossover study to evaluate the efficacy and safety of Zestra for Women compared to placebo oil in 10 women with and 10 women without female sexual arousal disorder (FSAD) in conditions of home use in conjunction with sexual activities. Subjects were screened by physical examination, sex therapist interviews, and questionnaires. We randomized qualified subjects to treatment paths and gave them 5 doses of test article and diaries to use at home. At Visit 2, we assessed them by questionnaires and gave them 5 doses of crossover test article and diaries to use at home. At the final visit, we assessed them with questionnaires. We assessed safety by adverse event reports and primary efficacy by responses to a diary question regarding satisfaction with arousal. Secondary efficacy instruments included remaining diary questions, recall-based questionnaires, global assessment questions, and a consumer-testing questionnaire. All 20 subjects completed the study. Three subjects reported single incidences of mild genital burning sensations lasting 5-30 min after use of Zestra for Women. Both normal and FSAD women showed statistically significant improvements, relative to placebo, in level of arousal, level of desire, satisfaction with arousal, genital sensation, ability to have orgasms, and sexual pleasure. Although FSAD women showed greater magnitude of response, the presence of FSAD had no effect on response rates. Zestra for Women was just as effective in women using selective serotonin reuptake inhibitor antidepressants as in women not using antidepressants. Zestra for Women improved sexual function in normal and FSAD women under conditions of home use. The references of this article are secured to subscribers.