Novel vaginal gel use for Vulvovaginal atrophy in women with breast cancer

Vulvovaginal atrophy (VVA) is a common condition in women associated with decreased estrogen levels in vaginal tissues. It often occurs during menopause or as a side effect of breast cancer therapies. Currently, the most effective treatment for VVA is topical estrogen, but its use in breast cancer patients is controversial due to systemic absorption concerns. This has created a need for safe alternatives such as Ospemifene. Ospemifene is an FDA-approved oral selective estrogen receptor modulator (SERM) for treating VVA symptoms. However, its limited bioavailability, delayed relief, and potential risks hinder its efficacy. To overcome these challenges, we propose developing a vaginal micro-sponge gel with Ospemifene as the active agent, aiming to provide a safe and effective topical therapy for VVA in breast cancer patients. Our first aim is to develop a unique gel formulation using Ospemifene, hyaluronic acid, glycerin, and a low-dose progestin to prevent endometrial cancer. We will evaluate the formulation's compatibility and stability under different vaginal conditions. In the second aim, we will assess the effectiveness of Ospemifene using an ex-vivo tissue model, evaluating its ability to promote vaginal tissue growth and regeneration. We will also examine its safety by assessing its impact on cervical-vaginal cell lines and lactobacillus viability. The third aim involves testing the gel on a VVA rat model to evaluate its efficacy and safety. By generating comprehensive data, we aim to establish a novel and safe route for Ospemifene administration, providing a viable alternative to topical estrogen for the treatment of VVA. This research has significant implications for improving the quality of life for women with a history of breast cancer. By offering a safe and effective therapeutic option, it addresses the limitations of current treatments and fills a crucial gap in VVA management