Abstract

A clinical study evaluating a single-dose, oral granule formulation of secnidazole 2 g for the treatment of bacterial vaginosis (BV) was conducted and the results have been reported. Since then, the US Food and Drug Administration (FDA) has issued updated guidelines for clinical studies evaluating treatments for BV. The purpose of this post hoc analysis was to determine the effects of the updated FDA criteria issued in 2016 on enrollment and clinical response rates.

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