Hillier SL, et al. – This study is performed to assess secnidazole as a single oral dose treatment for bacterial vaginosis in phase 2 randomized, double–blind, placebo–controlled study. Oral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P<.001 for both groups). This information supports the development of secnidazole for bacterial vaginosis treatment.

Methods

• For this research, they conducted 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 enrolled in this study.
• All the participants 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, characterized as a Nugent score of 0–3, and therapeutic cure, characterized as meeting criteria for both clinical and microbiologic cure.
• The modified intent to treat was used for efficacy investigations 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 an important difference between groups (.05 level [two–sided]) utilizing a Cochran–Mantel–Haenszel test.

Results

• For this study, they designed a randomized controlled trial.
• In this study, they enrolled total 215 patients between May and September 2014.
• 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).
• They noticed both doses were well–tolerated.