Intravaginal Metronidazole/Miconazole for the Treatment of Vaginal Trichomoniasis

Schwebke, Jane R. MD*; Lensing, Shelly Y. MS; Sobel, Jack MD

doi: 10.1097/01.olq.0000431069.38601.d5
Original Study

Background: Trichomonas vaginalis is the causative agent of the most common curable sexually transmitted disease in the world. The infection is treated with a single oral dose of metronidazole or tinidazole, currently the only licensed class of drugs available for this indication; however, both of these antimicrobials are associated with significant gastrointestinal adverse effects, and some individuals are unable to tolerate them because of these adverse effects.

Methods: Randomized, dose-ranging pilot study conducted in 2 phases consisting of 20 participants in each phase. In the first phase, participants were randomized to the vaginal suppository (metronidazole 750 mg/miconazole nitrate 200 mg) twice a day for 7 days versus oral metronidazole 2 g single dose. In the second phase, participants randomized to suppository used it once a day for 7 days. Women were reevaluated on days 12 to 15 and 30 to 35. Treatment failures were defined as persistence of trichomonas by wet prep and/or culture.

Results: There were no significant differences in cure rates between the vaginal suppositories and oral metronidazole in either phase. The overall efficacy across both follow-up visits was 80% versus 90% for the suppository (2×/d) versus oral medication arms in phase 1 (P = 1.00) and 78% versus 70% for the suppository (1×/d) versus oral medication arms in phase 2 (P = 1.00). The results were also nonsignificant when combining results across arm (P = 1.00).

Conclusions: High-dose intravaginal metronidazole combined with miconazole offers the possibility of a well-tolerated treatment that avoids the systemic adverse effects of nitroimidazoles for the treatment of trichomoniasis.

A pilot study comparing intravaginal metronidazole/miconazole with oral metronidazole for vaginal trichomoniasis found the 2 treatments to be equivalent.

From the *Department of Medicine, University of Alabama at Birmingham, Birmingham, AL; †Department of Biostatistics, University of Arkansas Medical Center, Little Rock, Arkansas; and ‡Department of Medicine, Wayne State University, Detroit, MI.

Supported by Embil Pharmaceuticals. Drs Sobel and Schwebke serve as consultants for this company. The remaining author has no conflict of interest.

Correspondence: Jane R. Schwebke, MD, 703 19th Street South, ZRB 239, Birmingham, AL 35294-0007. E-mail: schwebke@uab.edu

Received for publication January 09, 2013, and accepted May 06, 2013.

© Copyright 2013 American Sexually Transmitted Diseases Association