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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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[2] A. Dupre, H.H. Alur, D.R. Friend. Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis[J]. Clinical and Experimental Obstetrics & Gynecology, 2020, 47(4): 516-518.
[3] S. Nayak, A. Avery, J. McLeod Griffiss, C.D. Charles, K.R. Culwell. A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH[J]. Clinical and Experimental Obstetrics & Gynecology, 2019, 46(5): 736-742.
[4] Kwan Young Oh, Seung Min Yoo, Yong Hak Sohn, Seong Sil Chang. Vaginal microbiota composition as a diagnostic tool for bacterial vaginosis in pregnant Korean women[J]. Clinical and Experimental Obstetrics & Gynecology, 2019, 46(1): 27-31.
[5] M.K. Figueiredo Facundo, C.R. de Souza Bezerra Sakano, C.R. Nogueira de Carvalho, A.M. de Oliveira Machado, N.M. de Góis Speck, J. Chamorro Lascasas Ribalta. Vaginal microbiota in asymptomatic Brazilian women with HIV[J]. Clinical and Experimental Obstetrics & Gynecology, 2017, 44(5): 704-709.
[6] P. Korrovits, E. Lapp, R. Mändar. Couple-related factors of ART outcome[J]. Clinical and Experimental Obstetrics & Gynecology, 2016, 43(5): 747-750.
[7] N. Güdücü, G. Gönenç, H. İşçi, A. Başgül Yig˘iter, N. Başsüllü, İ. Dünder. Clinical importance of detection of bacterial vaginosis, trichomonas vaginalis, candida albicans and actinomyces in Papanicolaou smears[J]. Clinical and Experimental Obstetrics & Gynecology, 2012, 39(3): 333-336.
[8] E. Caliskan, Y. Cakiroglu, D. Dundar, E. Doger, S. Caliskan, S. Ozeren. Integrating cervical length measurement into routine antenatal screening and only emergency cerclage when indicated[J]. Clinical and Experimental Obstetrics & Gynecology, 2009, 36(1): 40-45.
[9] E. D. Hapsari, M. Hayashi, H. Matsuo. Clinical characteristics of vaginal discharge in bacterial vaginosis diagnosed by Nugent's criteria[J]. Clinical and Experimental Obstetrics & Gynecology, 2006, 33(1): 5-9.
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