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Daré Bioscience Announces Availability of Publication on the Patient-Centered Concept Elicitation Study for Female Sexual Arousal Disorder in The Journal of Sexual Medicine
The Concept Elicitation Study Informed the Selection of the Primary, Secondary, and Exploratory Endpoints Included in the Phase 2b RESPOND Clinical Study
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"The Concept Elicitation Study Informed the Selection of the Primary, Secondary, and Exploratory Endpoints Included in the Phase 2b RESPOND Clinical Study Evaluating the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients with Female Sexual Arousal Disorder Topline Data from the Exploratory Phase 2b RESPOND Study are Anticipated 2Q-2023 SAN DIEGO, May 31, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the publication of results of the patient-centered study designed to elucidate the commonly reported symptoms, including severity of symptoms, associated with female sexual arousal disorder (FSAD). The publication, “Symptoms and associated impact in pre-and postmenopausal women with sexual arousal disorder: a concept elicitation study,” appears in The Journal of Sexual Medicine. The concept elicitation study, also referred to as a content validity study, to explore the experience of condition-associated symptoms and the relative importance of FSAD symptoms, including their severity, bother, and impact, on participants’ health-related quality of life in pre- and postmenopausal women with FSAD was completed prior to commencement of the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, topline data for which are anticipated during 2Q-2023. The non-interventional study was conducted to identify and document the genital arousal symptoms that are the most problematic and most important symptoms to treat for women with FSAD. The findings of this content validity study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the exploratory Phase 2b RESPOND study and future Phase 3 program, including a number of exploratory endpoints informed by the findings of the content validity study. The content validity study included in-depth, qualitative, semi-structured concept elicitation interviews with premenopausal (n=23) and postmenopausal (n=13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician. The qualitative data from the interviews revealed a substantial physical and emotional burden of FSAD. The symptoms and impacts of this condition underscore the need for FDA-approved treatment options for pre- and postmenopausal women with FSAD. Results from this study also suggest that the ma...