Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis

ABSTRACT Objective Astodrimer is a dendrimer formulated in a vaginal gel to treat bacterial vaginosis (BV) and prevent recurrence. The objective of these studies was to confirm the efficacy and safety of Astodrimer 1% Gel for treatment of BV. Study Design Women with bacterial vaginosis were randomized 1:1 to Astodrimer 1% Gel (Study 1 conducted in the United States, N = 127; Study 2 conducted in the United States, Germany and Belgium, N = 128) or placebo gel (Study 1, N = 123; Study 2, N = 123) at a dose of 5 g vaginally once daily for 7 days. The primary endpoint was clinical cure, defined as i) absence of bacterial vaginosis vaginal discharge; ii) Results Astodrimer 1% Gel was superior to placebo for the primary and selected secondary efficacy measures. Clinical cure rates at day 9-12 were 50.4% (59/117) vs 16.5% (19/115, P  Conclusion These results support a role for Astodrimer 1% Gel as an effective, safe and well-tolerated treatment for women with bacterial vaginosis.