Comparison of once-daily and twice-daily dosing of 0.75% metronidazole gel in the treatment of bacterial vaginosis

Charles H. Livengood, David E. Soper, Katharine L. Sheehan, Dee E. Fenner, Mark G. Martens, Anita L. Nelson, Mahmoud Ismail, John M. Thorp, Myra Lappin, Barbara J. Long, Theodore Blackwelder, Richard L Sweet, Stanley Sagov

Research output: Contribution to journalArticle

41 Scopus citations

Abstract

Background and Objectives: Bacterial vaginosis is the most common cause of vaginal symptoms in women and has potential complications. Efforts to improve treatment of this disease process are warranted. Goal of this Study: The goal of this study was to compare the safety and efficacy of once-daily intravaginal administration of 0.75% metronidazole gel for 5 days to the established twice-daily regimen in the treatment of bacterial vaginosis. Study Design: Nonpregnant women with bacterial vaginosis diagnosed by accepted clinical criteria at 14 geographically diverse general gynecology clinics were enrolled in this prospective, randomized, investigator-blind, parallel study. They were treated with either once-daily or twice-daily 0.75% metronidazole gel 5 g intravaginally for 5 days and were reevaluated at 7 to 12 days and 28 to 35 days after completing treatment. Efficacy was determined by clinical criteria. Adverse drug reactions were monitored. Results: Of the 514 evaluable women enrolled, bacterial vaginosis was cured at the first return visit among evaluable patients in 153 of 199 (77%) of those who received the once-daily and in 157 of 196 (80%) of those who received the twice-daily administration. Bacterial vaginosis was cured among evaluable patients at the final visit in 104 of 180 (58%) of those who received once- daily and 109 of 178 (61%) of those who received the twice-daily regimen. Intent-to-treat analysis showed cure at 1 month in 118 of 207 (57%) of those treated once daily and 129 of 209 (62%) of those treated twice daily. Side effects were mild, and none caused treatment discontinuation. Conclusions: Once-daily dosing of 0.75% metronidazole gel 5 g for 5 days yields efficacy, safety, and tolerance equivalent to the currently used twice-daily dosing in the treatment of bacterial vaginosis, adding another competitive choice to the available therapeutic options for this condition.

Original languageEnglish (US)
Pages (from-to)137-142
Number of pages6
JournalSexually Transmitted Diseases
Volume26
Issue number3
StatePublished - Mar 1999
Externally publishedYes

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Microbiology (medical)

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    Livengood, C. H., Soper, D. E., Sheehan, K. L., Fenner, D. E., Martens, M. G., Nelson, A. L., Ismail, M., Thorp, J. M., Lappin, M., Long, B. J., Blackwelder, T., Sweet, R. L., & Sagov, S. (1999). Comparison of once-daily and twice-daily dosing of 0.75% metronidazole gel in the treatment of bacterial vaginosis. Sexually Transmitted Diseases, 26(3), 137-142.