title: Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study.
abstract: OBJECTIVE
  Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration-approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that a shorter treatment course at a higher dose (MVG 1.3%) would yield similar efficacy to 5 days of MVG 0.75%.
  
  
  METHODS
  This phase 2, multicenter, randomized, controlled, investigator-blinded, dose-ranging study enrolled women with a clinical diagnosis of BV. Patients were assigned to MVG 1.3% once daily for 1, 3, or 5 days or MVG 0.75% once daily for 5 days. The therapeutic cure rate, requiring clinical and bacteriological cure, at the end-of-study visit was determined for the per-protocol population. A Kaplan-Meier analysis was used to estimate median time-to-symptom resolution.
  
  
  RESULTS
  In total, 255 women (mean age = 35 y) were enrolled. The per-protocol population included 189 patients. The therapeutic cure rate was higher in the 1-day (13/43, 30.2%), 3-day (12/48, 25.0%), and 5-day (16/49, 32.7%) MVG 1.3% groups versus the MVG 0.75% group (10/49, 20.4%). Median time-to-resolution of fishy odor was shorter in the 3 MVG 1.3% groups versus the MVG 0.75% group. The 5-day MVG 1.3% group had the lowest rate of symptom return. No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment. Similar results were found in the modified intent-to-treat population.
  
  
  CONCLUSIONS
  Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.
authors.affiliation: 1Segal Institute for Clinical Research, North Miami, FL; 2TMC Life Research, Inc., Houston, TX; 3Atlanta North Gynecology, P.C., Roswell, GA; 4Downtown Women's Health Care, Denver, CO; 5Prosoft Clinical, Wayne, PA; 6Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA; and 7Department of Obstetrics and Gynecology, Drexel University, Philadelphia, PA.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Chavoustie
authors.forename: Mark
authors.initials: M
authors.lastname: Jacobs
authors.forename: Howard A
authors.initials: HA
authors.lastname: Reisman
authors.forename: Arthur S
authors.initials: AS
authors.lastname: Waldbaum
authors.forename: Sharon F
authors.initials: SF
authors.lastname: Levy
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
authors.forename: Paul
authors.initials: P
authors.lastname: Nyirjesy
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage* / Q000009:adverse effects; D016585:Vaginosis, Bacterial / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D014622:Vaginal Creams, Foams, and Jellies; D008795:Metronidazole