(053) THE CONSORTIUM FOR THE STUDY OF WOMEN’S SEXUAL WELLNESS: RATIONAL, MISSION AND CALL TO ACTION

Abstract

Abstract Introduction Female sexual wellness products have been growing and this growth was accelerated during the pandemic and the increased interest in self-care. While trying to find a place in beauty, sexual wellness really is only slightly beauty-adjacent. The beauty industry is built on delivering many products based solely on a promise. Little science is applied in this field to show any MOA or clinical efficacy. However, even in this sector the status quo is being disrupted by the FDAs Modernization of Cosmetic Regulations Act of 2022 (MoCRA). However, sexual wellness products are really more pharma-adjacent, even while using non-pharmaceuticals (nutraceuticals) ingredients. We reviewed all non-device based sexual wellness products that claimed functional benefit and based on these results, we make some recommendations. Objective To challenge the female sexual wellness industry to adopt basic and clinical science in the development and marketing of female sexual wellness products. Methods Over a three-year span, we reviewed the ingredients and claims as well as any clinical trial data on products claiming a functional benefit in sexual desire, arousal and/or orgasm. Following the unsurprising findings, we propose a number of solutions. Results Without naming the companies or products, we found an abundance of unusual products that did not seem to have a scientific rationale for ingredients and virtually all claims were unsubstantiated. Two entities have performed clinical studies. The first is a cannabis company which performed a study without a validated instruments and soft-endpoints, and as expected, there was a 100% response rate. The second entity has performed pre-clinical studies (organ bath and MOA studies) and an open-label pilot study employing a modified FSFI and diary data and efficacy and safety output. However, this was not a randomized, double-blind, placebo-controlled study. Conclusions Seismic changes are happening in the beauty and wellness industry. Female sexual wellness is closely pharma-adjacent and, as such, should adopt the preclinical and clinical trial approach that has already been developed for the evaluation of drugs in female sexual dysfunction. While these agents may only enhance normal function and don’t treat diseases or disorders, the learnings from the last half century in sexual pharmacotherapy are readily adapted to the development and evaluation of sexual wellness products. Vella Bioscience is rapidly moving to follow these principles, as follows: 1. We are performing a three-month RCT with liposomal cannabidiol vs placebo that has been powered to demonstrate statistical and clinical significance. The outcome instruments include both the PROMIS database and diary data. 2. The establishment of the Consortium for the Study of Women’s Sexual Wellness, with the following mission: Bring scientific rigor to the basic science and clinical science research of sexual wellness products, including the utilization of double-blind, placebo-controlled, randomized clinical trials. Support research, education, and public awareness of female sexual health and wellness. Enable healthcare providers and customers to directly access research protocols and validated products for the management of sexual wellness. Critical to this mission are the members of the Scientific Advisory Board of the Consortium, including Alan Altman, MD, FACOG, Anita Clayton, MD, Peter Fodor, MD, FACS, Sheryl Kingsberg, PhD, Cindy Meston, PhD, James Pfaus, PhD, Nicole Prause, PhD, Raymond Rosen, PhD, and James Simon, MD, FACOG. We invite other corporate entities to utilize the consortium and we hope that ISSWSH will adopt these principles as well. Women deserve data and not a promise. Disclosure Yes, this is sponsored by industry/sponsor: Vella Bioscience, Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Vella Bioscience, Inc.