Dare Bioscience and its collaborator Strategic Science & Technologies announced additional positive findings based on further analyses of data from the exploratory Phase 2b RESPOND study that evaluated Sildenafil Cream, 3.6% in women with female sexual arousal disorder, FSAD. The Phase 2b RESPOND study enrolled women with FSAD and included women who had sexual dysfunctions in addition to FSAD. Further analyses of Phase 2b RESPOND study data identified a subset of study participants-women with FSAD as well as women with FSIAD whose primary complaint was arousal dysfunction-that achieved statistically significant and clinically meaningful improvement in the Phase 2b co-primary endpoint of evaluating the efficacy of Sildenafil Cream versus placebo cream as measured by change from baseline to the end of the 12-week double-blind dosing period in the Arousal-Sensation Domain of the Sexual Function Questionnaire. The other co-primary objective of the Phase 2b RESPOND study was to evaluate the efficacy of Sildenafil Cream compared to placebo cream as measured by the change from baseline to the end of the 12-week double-blind dosing period in the score for feeling concerned by difficulties with sexual arousal utilizing the Female Sexual Distress Scale – Desire, Arousal, Orgasm. Analyses of the same subset of women in the Phase 2b RESPOND study demonstrated that the Sildenafil Cream treatment group achieved statistically significant improvement in several FSDS-DAO questions, including regarding guilt, stress, inadequacy, and embarrassment due to their sexual problems.
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