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Daré Bioscience Announces Publication in The Journal of Sexual Medicine of Positive Findings from the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6%
Published data show that responses from 1-month and 24-hour recall patient reported outcome (PRO) instruments were similar and support that either method
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Published data show that responses from 1-month and 24-hour recall patient reported outcome (PRO) instruments were similar and support that either method could be used to assess treatment efficacy in future clinical studies Longer recall intervals for PRO assessments are less burdensome to clinical study participants and may improve data collection compliance SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has been published by The Journal of Sexual Medicine. Publication Details: Johnson, et al. “Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder.” The Journal of Sexual Medicine, 2024 [Preprint] https://doi.org/10.1093/jsxmed/qdae086 “In this first-of-its-kind study in FSAD patients, we are very pleased to be able to share these data,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Being able to show consistent results from patient reported outcome measures, regardless of whether she is recalling her experiences over the last month or the last day, provides important optionality as we consider how to clinically measure the impact of Sildenafil Cream on patients with FSAD.” “This preplanned subset analysis was intended to investigate whether there were differences in outcomes when assessing arousal sensation on 24-hour vs 1-month PRO instruments,” said Dr. Annie Thurman, MD, FACOG, Medical Director at Daré Bioscience. “We were thrilled to see the strong correlation between the 24-hour recall eDiary and the 1-month recall instrument scores since the 1-month recall is significantly less burdensome for patients. With a condition that’s often dismissed and stigmatized, it's important to show that we can collect accurate data to assess efficacy of Sildenafil Cream in a way that’s easily manageable for patients.” The exploratory Phase 2b RESPOND study wa...