Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis
Journal Title: Clinical and Experimental Obstetrics & Gynecology - Year 2019, Vol 46, Issue 4
Abstract
Summary 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.
Authors and Affiliations
P. Nyirjesy, M. Padula, J. L. Amprey
Keywords
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- EP ID EP673404
- DOI 10.12891/ceog4892.2019
- Views 72
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