A single oral dose of secnidazole 2 g was safe and efficacious for the treatment of bacterial vaginosis, according to the results of a phase 3 study published in the American Journal of Obstetrics & Gynecology.
Women with bacterial vaginosis were randomly assigned to receive a single dose of secnidazole 2 g (n=125) or placebo (n=64). Rate of clinical response was the primary outcome, and clinical cure rate was the secondary outcome. Clinical cure, which was evaluated according to 2 distinct measures of vaginal discharge, evaluated the following factors: normal vaginal discharge (2016 US Food and Drug Administration [FDA] draft guidance) or normal vaginal discharge or abnormal vaginal discharge unrelated to bacterial vaginosis (modified criteria); negative 10% potassium hydroxide whiff test; and <20% clue cells of total epithelial cell count on microscopic examination of the vaginal wet mount (study days 21 to 30). Safety and tolerability were assessed throughout.
Compared with the placebo group, the secnidazole group had a significantly better clinical response rate (53.3% vs 19.3%; P <.001) and clinical cure rates (58.9% vs 24.6% for modified criteria; 64.0% vs 26.4% for FDA criteria in women with baseline Nugent scores of 7 to 10).
Furthermore, significantly fewer women who received secnidazole required additional bacterial vaginosis treatment compared with placebo (68.0% vs 29.6%; P <.001).
Treatment-related adverse events included diarrhea (4.0% vs 1.6% for secnidazole vs placebo), headache (4.0% vs 3.1%), nausea (4.8% vs 1.6%), and vulvovaginal candidiasis (4.0% vs 3.1%).
The study investigators concluded that the results “support [secnidazole as] an effective and well-tolerated treatment for [bacterial vaginosis…A single-dose treatment option may improve treatment adherence, which may be beneficial for both patients and healthcare practitioners.”
Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis [published online September 1, 2017]. Am J Obstet Gynecol. doi: 10.1016/j.ajog.2017.08.017