title: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis.
abstract: BACKGROUND
  Bacterial vaginosis (BV), a prevalent infection in women of reproductive age, is associated with increased risk of upper genital tract and sexually transmitted infections, and complications in pregnancy. Currently approved treatments include metronidazole, which requires once or twice daily intravaginal administration for 5 days or twice daily oral administration for 7 days. This phase 3 study determined the safety and efficacy of single-dose metronidazole vaginal gel (MVG) 1.3%.
  
  
  METHODS
  In this double-blind, vehicle-controlled study, 651 women with clinical diagnosis of BV were randomized 1:1 to receive MVG 1.3% or vehicle vaginal gel. Primary efficacy measure was clinical cure (normal discharge, negative "whiff test," and <20% clue cells) at day 21. Secondary measures included therapeutic cure (both clinical and bacteriological; day 21) and bacteriologic cure (Nugent score <4), clinical cure, and time to resolution of symptoms (day 7).
  
  
  RESULTS
  A total of 487 participants were included in the primary analysis. Clinical and therapeutic cure rates (day 21) were higher in participants treated with MVG 1.3% compared with vehicle gel (37.2% vs. 26.6% [P = 0.010] and 16.8% vs. 7.2% [P = 0.001], respectively). Clinical and bacteriologic cure rates (day 7) were also higher in the MVG 1.3% group (46.0% vs. 20.0% [P < 0.001] and 32.7% vs. 6.3% [P < 0.001], respectively). The median time to resolution of symptoms was shorter in the MVG 1.3% (day 6) than vehicle group (not reached). No serious adverse events were reported, and incidence was similar across treatment groups.
  
  
  CONCLUSIONS
  Single-dose MVG 1.3% was safe and superior to vehicle gel in producing cure among women with BV.
authors.affiliation: From the *Department of Medicine, University of Alabama at Birmingham, Birmingham, AL; †Division of Allergy & Infectious Diseases, University of Washington, Seattle, WA; ‡Formerly of Watson Laboratories, Inc, a subsidiary of Actavis, Inc, Salt Lake City, UT; and §Department of Internal Medicine, Wayne State University School of Medicine, Detroit, MI.
authors.forename: Jane R
authors.initials: JR
authors.lastname: Schwebke
authors.forename: Jeanne
authors.initials: J
authors.lastname: Marrazzo
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Beelen
authors.forename: Jack D
authors.initials: JD
authors.lastname: Sobel
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage*; D009812:Odorants; D010349:Patient Compliance; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D019522:Vaginal Discharge / Q000382:microbiology*; D016585:Vaginosis, Bacterial / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology
chemical_list: D000900:Anti-Bacterial Agents; D014622:Vaginal Creams, Foams, and Jellies; D008795:Metronidazole