Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial



Title: Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial

Hillier, SL et al.


 

What You Need to Know:

According to results of a phase 2 study, 1 and 2 g doses of secnidazole were more effective in the treatment of bacterial vaginosis compared to placebo.

Trial Design:

  • Double-blind, placebo-controlled, phase 2 trial assessed the effectiveness of a single dose of secnidazole in the treatment of bacterial vaginosis
  • 215 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 (1:1) to receive oral granules containing 1g or 2g of secnidazole or placebo
  • Primary endpoint: clinical cure measured 21 to 30 days after therapy (defined as discharge, amine odor, and clue cell normalization)
  • Secondary endpoints: microbiologic cure (a Nugent score of 0-3), therapeutic cure (attained if clinical and microbiologic cure criteria are met)
  • Utilized modified intention-to-treat analysis, which included 188 women total

Key Outcomes:

  • Clinical cure rates in the intention-to-treat population: 65.3% for patients who received 2g secnidazole, 49.3% for patients who received 1g secnidazole, and 19.4% for patients who received placebo
  • “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 1g and 2g doses of secnidazole were well tolerated