A comparative study of butoconazole, miconazole and placebo
Dyck, W.A. van, Jr
Journal of Reproductive Medicine 31(7(Supplement)): 662-663
The objective of our investigation was to evaluate the safety, tolerance and effectiveness of both 1% and 2% butoconazole nitrate vaginal cream in the treatment of vulvovaginal candidiasis. The compound was applied for either three or six days, and its effects were compared to six-day treatment with 2% miconazole and with the vehicle cream as a placebo. The trial was conducted as a multicenter study using a parallel, double-blind design. Patients with clinical signs and symptoms of vulvovaginal candidiasis and who had positive wet mount preparations and cultures for Candida were enrolled. Women with trichomonads and/or clue cells in the wet smear were not eligible to participate in the study. Patients who fulfilled the protocol admission criteria were assigned to the following treatment groups: butoconazole 1% for three days followed by placebo for 3 days, butoconazole 1% for 6 days, butoconazole 2% for 3 days followed by a placebo for 3 days, butoconazole 2% for 6 days, miconazole 2% for 6 days or the vehicle for 6 days. The efficacy of the study drugs was judged by the duration of relief from the clinical signs and symptoms of vaginitis and the absence of Candida albicans, microorganisms and vaginal secretions, as established by fungal culture and potassium hydroxide preparation.