Objectives
SYM-1219, a granule formulation of secnidazole, is being developed as a single oral dose therapy for bacterial vaginosis (BV). A previous study of SYM-1219 for the treatment of BV demonstrated efficacy of 1 g and 2 g of secnidazole compared to placebo, with exceptional safety and tolerability. The objective of this study was to confirm the efficacy and safety of SYM-1219 granules containing 2 g of secnidazole compared to placebo for the treatment of BV.
Methods
189 women who met the 4 Amsel criteria for BV (discharge characteristic of BV, pH ≥4.7, ≥20% clue cells, positive whiff test) were randomized 2:1 at 22 US sites and received single oral doses of 2g of secnidazole as SYM-1219 granules or placebo. The randomization was stratified by number of reported prior episodes of BV (<3 versus ≥4 episodes within 12 months) and by race (Black versus others). Nugent score ≥4 was required for inclusion in the efficacy analyses. Patients were evaluated for efficacy between days 7-14 (interim visit) and between days 21-30 (EOS). The primary endpoint was clinical response (CR) at EOS defined as a normal vaginal discharge, negative whiff test, and clue cells <20%. Microbiological cure was a Nugent score of <4. The modified Intention-to-Treat (mITT) population was used for the efficacy analyses. Statistical comparisons used a stratified Cochran-Mantel-Haenszel (CMH) test performed at a 0.05 level of significance (2-sided).
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