IMR Press / CEOG / Volume 46 / Issue 4 / DOI: 10.12891/ceog4892.2019

Clinical and Experimental Obstetrics & Gynecology (CEOG) is published by IMR Press from Volume 47 Issue 1 (2020). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on as a courtesy and upon agreement with S.O.G.

Open Access Original Research
Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis
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1 Department of Obstetrics and Gynecology, Drexel University College of Medicine, Philadelphia, PA, USA
2 Virtuoso Healthcare Group, Manhasset, NY, USA
3 Symbiomix Therapeutics, Newark, NJ, USA
*Correspondence: (P. NYIRJESY)
Clin. Exp. Obstet. Gynecol. 2019, 46(4), 615–617;
Published: 10 August 2019

Purpose of Investigation: In 2016, the US Food and Drug Administration updated the enrollment and clinical response criteria for clinical studies of bacterial vaginosis (BV). The purpose of this post hoc analysis was to determine the effects of these differences on the results of a previously published phase 3 clinical study of the use of a single oral dose of secnidazole 2 grams to treat BV. Results: The updated guidelines for enrollment include a more stringent baseline Nugent score cutoff, which reduced the number of subjects from the initial study by 16.8% (secnidazole group) and 7.0% (placebo group). The updated efficacy guidelines changed the clinical outcome responder rates to 64.0% (secnidazole) and 26.4% (placebo) on assessment days 7-14 (p < 0.001), and to 58.4% and 24.5%, respectively, on days 21-30 (p < 0.001). Conclusion: Although the guidelines did not significantly affect efficacy outcomes, future BV studies will need to screen more patients to compensate for the new, more stringent enrollment criteria.

Bacterial vaginosis
Nugent score
Single-dose treatment
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