16: A phase 3 randomized, double-blind, placebo-controlled study to confirm the efficacy and safety of a single, oral dose of SYM-1219, a granule formulation containing 2 grams of secnidazole, for the treatment of bacterial vaginosis
American Journal of Obstetrics and Gynecology(2016)
摘要
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.
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关键词
Vaginal Microbiome
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