Three-day treatment with butoconazole nitrate for vulvovaginal candidiasis
Droegemueller, W.; Adamson, D.G.; Brown, D.; Cibley, L.; Fleury, F.; LePage, M.E.; Henzl, M.R.
Obstetrics and Gynecology 64(4): 530-534
1984
ISSN/ISBN: 0029-7844 PMID: 6384848 Document Number: 232594
A multicentre clinical trial of 274 patients compared the efficacy and safety of butoconazole nitrate cream 2% to clotrimazole vaginal tablets 200 mg/day. Both drugs were administered for 3 days. The patients were randomly assigned to one or the other treatment regimen. Eight days after treatment completion, Candida albicans was absent in vaginal cultures of 95% of patients receiving butoconazole and of 91% of patients receiving clotrimazole; 30 days after treatment completion, 80% of patients receiving butoconazole were free of the fungal infection; the corresponding number for clotrimazole was 74%. Complete absence of signs and symptoms of vulvovaginal candidosis was noted in 82% of patients receiving butoconazole and 72% of patients receiving clotrimazole. Phamacokinetic parameters were studied in 3 women volunteers who received one dose of radiolabeled butoconazole nitrate vaginal cream 2%. Measurable levels of radioactivity were not detected until 2-8 h after vaginal administration of the compound. Max. plasma levels of radioactivity were achieved 24 h after dosing and ranged from 19 to 44 ng/ml and fell to background levels after 96-120 h. Total radioactivity was excreted to an equal extent in urine (2.7%) and in faeces (2.8%).