Metronidazole-containing vaginal sponges for the treatment of bacterial vaginosis.
Currently, there is no FDA approved treatment for bacterial vaginosis (BV), although various oral dosages of metronidazole are used to treat this condition. A vaginal therapeutic sponge (VLI Corporation) that releases metronidazole over a 24 h use period has been developed for the treatment of BV. Each sponge contains 250 mg of metronidazole. The safety and effectiveness of using one or three metronidazole-containing vaginal sponges for the treatment of BV was evaluated in 40 patients. Use of a single sponge resulted in a cure rate of 38.9%. With three sponges the cure rate was 94.4%. Cure was defined as the absence of signs and symptoms (vaginal discharge, elevated pH, KOH prep odor, and 'clue' cells) at the one and four week follow-up visits. The sexual partners of most women were also treated with metronidazole (2 g po in one dose). None of the women were discontinued from treatment because of any adverse effects. Side-effects were minimal and required no treatment. The cure rate with the three vaginal sponge dosage appears to be similar to that associated with oral dosages of metronidazole.
D000282:Administration, Intravaginal; D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D006194:Gardnerella vaginalis; D006192:Haemophilus Infections / Q000188:drug therapy*; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D011897:Random Allocation; D014627:Vaginitis / Q000188:drug therapy*
D008795:Metronidazole