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Pilot Randomized Trial for Treatment of Bacterial Vaginosis using In Situ Forming Metronidazole Vaginal Gel

Research Authors
Omar M. Shaaban, Gihan N. Fetih, Noura H. Abdellah, Sayed Ismail, Maggie A. Ibrahim, El-Sayed A. Ibrahim
Research Department
Research Journal
J. Obstet. Gynaecol. Res.
Research Rank
1
Research Vol
Vol. 37, No. 7
Research Year
2011
Research Abstract

Aim: To compare the efficacy of a novel vaginal delivery system for metronidazole (0.8% MTZ in situ gel) versus a conventional MTZ vaginal gel product in the treatment of bacterial vaginosis (BV).
Material and Methods: All consecutive patients who presented to a tertiary care hospital with symptoms suggestive of BV were approached to participate in the study. Forty-two eligible participants were randomly assigned to either MTZ in situ gel or a conventional vaginal gel product twice daily for 5 days. All participants were re-examined after one and 4 weeks of the beginning of treatment to ensure cure of infection and any side-effects.
Results: Demographic criteria of the participants were comparable in the two treatment groups. The cure rate after one week from the treatment was 85% in the in situ gel group and 71.4% in the conventional vaginal gel group (P = 0.294), while after 4 weeks, the cure rate showed significant difference in the in situ gel group as compared to the conventional vaginal gel group (16/20 [80%]) and (9/19 [47.4%]), respectively (P = 0.034).
Conclusion: Pilot testing showed that in situ MTZ vaginal gel is more effective than the conventional vaginal gel for long-term cure of BV. These findings suggest a novel and efficient long-term treatment of BV.