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%.
Materials and 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.
Metronidazole vaginal gel 1.3% once daily for 1, 3, or 5 days provides similar efficacy, safety, and tolerability as metronidazole vaginal gel 0.75% once daily for 5 days.
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
Reprint requests to: Paul Nyirjesy, MD, Department of Obstetrics and Gynecology, Drexel University, 216 N Broad St, Feinstein Bldg, 4th Floor, Philadelphia, PA 19102. E-mail: Paul.Nyirjesy@DrexelMed.edu
Writing and editorial assistance were provided by Peloton Advantage, LLC, and Scientific Connexions, funded by Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals.
Steven E. Chavoustie has received honoraria/speaking fees from Medicis Global Services Corporation. Arthur S. Waldbaum has received consulting fees from Medicis as payment for being an investigator in the study. Sharon F. Levy was employed by Graceway Pharma, original study sponsor, during the time of the study. After study completion, Dr. Levy has been employed by Prosoft Clinical, which has consulted on other projects with Valeant. Sharon L. Hillier has received no financial remuneration in the area of vaginitis; the University of Pittsburgh was compensated for the laboratory component of this study by Medicis and received NIH grant support. Dr. Hillier has served on advisory boards for Merck for antiretroviral drugs and has received from University of Toronto and State University of New York travel/accommodations/meeting expenses unrelated to the study in this article. Paul Nyirjesy has received consulting and research grants from Medicis Pharmaceutical Corporation. Mark Jacobs and Howard A. Reisman have no conflicts of interest to declare. This study was sponsored by Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals. Clinical Trial Registration: NCT01055106
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