INTRODUCTION: To date, no approved medication is available for the treatment of female sexual arousal disorder (FSAD). AIM: The purpose of this study was to evaluate the clinical efficacy and safety of a novel alprostadil topical cream for the treatment of FSAD. METHODS: This was a multicenter, randomized, double blind, placebo-controlled, parallel design dose-ranging study. Four hundred female patients with FSAD (22-62 years of age), after a 4-week nontreatment baseline period, were provided with 10 blinded doses of 500, 700, or 900 mcg alprostadil or a placebo cream to be applied to the clitoris and the G-spot in the vagina prior to vaginal intercourse. MAIN OUTCOME MEASURES: The primary efficacy end point was the arousal success rate (equal number of the Yes responses to Question 3 of the Female Sexual Encounter Profile [FSEP] or number of the sexual encounters). Secondary endpoints included the Female Sexual Function Index (FSFI), Global Assessment Questionnaire, other FSEP question responses, and post-treatment changes in Female Sexual Distress Scale. RESULTS: A total of 374 FSAD patients completed the study. Primary efficacy analysis of the intent-to-treat (ITT) population showed a significant increase in arousal success rates with dose. Arousal success rates at the end of the total evaluation period were 33.1%, 46.3% (P = 0.0161), 43.5% (P = 0.0400), and 53.9% (P = 0.0002) in the placebo, 500, 700, and 900 mcg alprostadil groups, respectively. The changes of the FSFI score, relative to baseline were 14.7%, 20.7% (P = 0.067), 21.7% (P = 0.035), and 22.9% (P = 0.002) for the placebo, 500, 700, and 900 mcg treatment groups, respectively. The other secondary efficacy end point values showed a consistent trend in support of the primary efficacy results. CONCLUSION: These results demonstrated that the application of topical alprostadil prior to vaginal intercourse significantly improved the sexual arousal rate of the subjects with FSAD.
RCT Entities:
INTRODUCTION: To date, no approved medication is available for the treatment of female sexual arousal disorder (FSAD). AIM: The purpose of this study was to evaluate the clinical efficacy and safety of a novel alprostadil topical cream for the treatment of FSAD. METHODS: This was a multicenter, randomized, double blind, placebo-controlled, parallel design dose-ranging study. Four hundred female patients with FSAD (22-62 years of age), after a 4-week nontreatment baseline period, were provided with 10 blinded doses of 500, 700, or 900 mcg alprostadil or a placebo cream to be applied to the clitoris and the G-spot in the vagina prior to vaginal intercourse. MAIN OUTCOME MEASURES: The primary efficacy end point was the arousal success rate (equal number of the Yes responses to Question 3 of the Female Sexual Encounter Profile [FSEP] or number of the sexual encounters). Secondary endpoints included the Female Sexual Function Index (FSFI), Global Assessment Questionnaire, other FSEP question responses, and post-treatment changes in Female Sexual Distress Scale. RESULTS: A total of 374 FSAD patients completed the study. Primary efficacy analysis of the intent-to-treat (ITT) population showed a significant increase in arousal success rates with dose. Arousal success rates at the end of the total evaluation period were 33.1%, 46.3% (P = 0.0161), 43.5% (P = 0.0400), and 53.9% (P = 0.0002) in the placebo, 500, 700, and 900 mcg alprostadil groups, respectively. The changes of the FSFI score, relative to baseline were 14.7%, 20.7% (P = 0.067), 21.7% (P = 0.035), and 22.9% (P = 0.002) for the placebo, 500, 700, and 900 mcg treatment groups, respectively. The other secondary efficacy end point values showed a consistent trend in support of the primary efficacy results. CONCLUSION: These results demonstrated that the application of topical alprostadil prior to vaginal intercourse significantly improved the sexual arousal rate of the subjects with FSAD.