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Clinical and Experimental Obstetrics & Gynecology  2019, Vol. 46 Issue (4): 615-617    DOI: 10.12891/ceog4892.2019
Original Research Previous articles | Next articles
Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis
P. Nyirjesy1, *(), M. Padula2, J.L. Amprey3
1Department of Obstetrics and Gynecology, Drexel University College of Medicine, Philadelphia, PA, USA
2Virtuoso Healthcare Group, Manhasset, NY, USA
3Symbiomix Therapeutics, Newark, NJ, USA
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Abstract  

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.

Key words:  Bacterial vaginosis      Nugent score      Secnidazole      Single-dose treatment      FDA     
Published:  10 August 2019     
*Corresponding Author(s):  P. NYIRJESY     E-mail:  paul.nyirjesy@drexelmed.edu

Cite this article: 

P. Nyirjesy, M. Padula, J.L. Amprey. Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis. Clinical and Experimental Obstetrics & Gynecology, 2019, 46(4): 615-617.

URL: 

https://ceog.imrpress.com/EN/10.12891/ceog4892.2019     OR     https://ceog.imrpress.com/EN/Y2019/V46/I4/615

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