Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)
pH-D Feminine Health LLC
Summary
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.
Description
This clinical study will be a multi-center, randomized, placebo-controlled, double-blinded study with a 3-arm design comparing 600 mg boric acid vaginal inserts dosed for 7 or 14 days to placebo. All patients will self-administer vaginal inserts once daily for 14 days. During self-administration of the study drug, patients will be instructed to utilize an electronic diary (eDiary) to record their daily symptoms from Screening through Day 28 (Visit 5). The following information will be recorded in the eDiary: * Study drug administration (including time at which study drug was administered, ac…