Bacterial Vaginosis (BV) Clinical Trial
Official title:
An Open-Label, Randomized Study to Determine the Safety and Efficacy of LUXSOL(TM) Cream for the Treatment of Bacterial Vaginosis: A Proof of Concept Study
LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..
LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of bacterial vaginosis (BV). The study is an open-label, randomized, controlled study comparing LUXSOL Cream to Metrogel in patients with a diagnosis of BV. The investigational product or the comparator product will be self-administered by the patient for 10 consecutive nights. A successful patient outcome is cured BV at 30 days. ;