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This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.
The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.
This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.