 Abstract from the 2001 Annual Meeting of the FSFF (Female Sexual Function Forum) held at the Marriott Copley Place in Boston, Massachusettes October 25-28, 2001
PURPOSE OF THE ORGANIZATION - The International Society for the Study of Women's Sexual Health is an international, multidisciplinary, academic, clinical and scientific organization whose purposes are: (1) to provide opportunities for communication among scholars, researchers and practitioners about women's sexual health, (2) to support the highest standards of ethics and professionalism in research, education and clinical practice of women's sexual health, and (3) to provide the public with accurate information about female women's sexual health. Presentation Abstract by David M. Ferguson, Ph.D., M.D., Consultant in Clinical Development RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, CROSSOVER DESIGN PILOT TRIAL OF THE EFFICACY AND SAFETY OF ZESTRA™ FOR WOMEN IN WOMEN WITH FEMALE SEXUAL AROUSAL DISORDER C Steidle, G Singh, S Alexander, K Weihmiller, D Ferguson, M Crosby, Grayslake, Illinois, USA Zestra™ for Women is a proprietary topical, oil-based formulation of scientifically studied botanicals with synergistic multiple mechanisms of action. The genital application of Zestra™ for Women is intended to facilitate female sexual arousal and enhance sexual pleasure. This product is developed and is intended to be marketed under the United States Cosmetics laws as a feminine massage oil. This pilot study was conducted to evaluate the efficacy and safety of Zestra™ for Women compared to a placebo oil in women with Female Sexual Arousal Disorder (FSAD) in conditions of home use in conjunction with sexual activities. For purposes of this study, primary efficacy assessment was focused on the patient's satisfaction and awareness of genital arousal based on diaries (Female Sexual Encounter Profile (FSEP)). Secondary evaluations of efficacy included a patient questionnaire (Female Sexual Function Index (FSFI)), two global assessment questions (GAQ), and a distress scale (Female Sexual Distress Scale (FSDS)). Forty women (age 21-65 years) diagnosed with FSAD and their sexually functional male partners signed informed consents to participate in this double-blinded, placebo-controlled, crossover design, home use study. Patients were postmenopausal, or using hormonal contraception for at least 3 months prior to study entry, or had had a documented tubal ligation at least 3 months prior to study entry. They were required to have previously been fully functional, now have a score of > 40 on the FSDS, and be willing to attempt sexual activities at least 3 times weekly. Patients were not excluded due to use of antidepressants, nutritional supplements, or hormonal replacement therapy. Patients were randomized to treatment paths and instructed in the use of the test article and the diaries. Ten doses of test article and ten diaries were dispensed with instructions to use them with each sexual encounter over the next few weeks. Follow-up telephone calls assessed progress and problems and allowed prompt scheduling of the second visit. At Visit 2, adverse events were recorded, diaries were reviewed, questionnaires were administered, and the genitals were examined. Crossover test article (10) and diaries (10) were dispensed and instructions were reviewed again. At Visit 3, adverse events were recorded, diaries were reviewed, questionnaires were administered, and the genitals were examined. The primary safety variables were adverse events and findings from the genital exams. The incidence of study-emergent adverse experiences were tabulated by treatment group, event, and body system. The overall incidence rates were compared between treatments using Pearson\'s chi-square tests. The primary efficacy parameter was the number of successes (adequate sexual arousal as indicated by YES responses to diary question 3) divided by the number of attempts. The secondary efficacy parameters were the responses to the global assessment questions, the responses to the remaining diary questions, changes in the responses to the Female Sexual Function Index, and changes in responses to the Female Sexual Distress Scale. Efficacy parameters were analyzed by ANOVA. Results were presented at the meeting. Please visit the ISSWSH website. |
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