To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study.
In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21–30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0–3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test.
Between May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (P<.05 for secnidazole compared with placebo; all endpoints). Both doses were well-tolerated.
Oral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P<.001 for both groups). These data support the development of secnidazole for bacterial vaginosis treatment.
Oral granules containing 1 and 2 g secnidazole were superior to placebo for treatment of bacterial vaginosis.
University of Pittsburgh and the Magee-Womens Research Institute, Pittsburgh, Pennsylvania; Drexel University School of Medicine, Philadelphia, Pennsylvania; Downtown Women's Health Care, Denver, Colorado; the University of Alabama at Birmingham, Birmingham, Alabama; Tidewater Clinical Research, Inc, Virginia Beach, Virginia; and Symbiomix Therapeutics, LLC, and SAJE Consulting LLC, Baltimore, Maryland.
Corresponding author: Sharon L. Hillier, PhD, Magee-Womens Research Institute, 204 Craft Avenue, B511 Pittsburgh, PA 15213; email: email@example.com.
Funding for this study was provided to Magee-Womens Research Institute (S.L.H.), Drexel University (P.N.), Downtown Women's Health Care (A.S.W.), the University of Alabama (J.R.S.), and Tidewater Clinical Research, Inc (F.G.M.) by Symbiomix Therapeutics, LLC, Baltimore, Maryland. Manuscript editing was also supported by Symbiomix Therapeutics, LLC.
Financial Disclosure Dr. Hillier has received compensation as a consultant for Symbiomix Therapeutics, LLC, Perrigo, Merck, and Cepheid Diagnostics. Drs. Hillier, Nyirjesy, Waldbaum, Schwebke, and Morgan all received grant support from Symbiomix Therapeutics, LLC, to their respective institutions for participation in this study. Ms. Adetoro and Dr. Braun (deceased) were employed by Symbiomix Therapeutics, LLC, during the conduct of this study.
Presented at the 42nd Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology, August 6–8, 2015, Portland, Oregon.
The authors thank Maryn Padula, PhD, of Virtuoso Healthcare Communications for assistance with manuscript editing.
Each author has indicated that he or she has met the journal's requirements for authorship.