Dare Bioscience, Inc a leader in clinical-stage women’s health innovation, today announced that it is currently enrolling patients in an investigational study designed to evaluate the feasibility of using thermography technology to assess the pharmacodynamics of Sildenafil Cream, 3.6% in normal healthy women. Sildenafil, the active ingredient in Sildenafil Cream, 3.6%, is marketed in an oral dosage form under the brand name Viagra(R) for the treatment of erectile dysfunction in men. Dare Bioscience, in partnership with Strategic Science & Technologies, LLC (SST), is developing Sildenafil Cream, 3.6% as a potential treatment for female sexual arousal disorder (FSAD). During the thermography study, genital temperature, a surrogate for genital blood flow, will be captured and recorded utilizing an infrared camera capable of detecting heat patterns from blood flow in body tissues. The study consists of the screening visit (visit 1), the double-blind dosing of placebo or active cream (visits 2-3) and a safety follow-up.
This non-interventional study is designed to explore the experience of FSAD and evaluate the relevance of the selected PRO measures based on patients’ own experiences and determine patients’ understanding of the items, instructions, and response options of the selected PRO measures. Subjects that meet the inclusion criteria will participate in one-on-one, in-depth interviews conducted by subject matter experts in the field of clinical outcome assessments and female sexual medicine, which include thought leaders in the field of sexual medicine that are a subset of the sites that are expected to enroll subjects into the Phase 2b at-home interventional study. This non-interventional content validity study provides a unique opportunity to pilot the methods intended to be used, subject to U.S. Food and Drug Administration approval.
About Sildenafil Cream, 3.6%
Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option. Unlike other female sexual disorders, FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty. It is the closest analog in women to erectile dysfunction in men. While increased attention has been focused on female sexual dysfunction over the past several years, no pharmacologic options have yet been U.S. Food and Drug Administration (FDA) approved for FSAD. In a Phase 2a trial, Sildenafil Cream, 3.6% increased measurable blood flow to the vaginal tissue in both pre- and postmenopausal women with FSAD compared to placebo.