Phase II trial: an evaluation of oral saperconazole in acute vaginal candidosis: a comparison of three dosage schedules.
In an open, randomized phase II comparative study, 256 patients with acute vaginal candidosis (less than two episodes of vaginal candidosis in the 6 months preceding study entry) were treated with saperconazole according to one of the following treatment schedules: 2 x 100 mg o.d. for 1 day (87 patients), 2 x 100 mg b.i.d. for 1 day (83 patients), or 2 x 100 mg o.d. for 2 days (86 patients). A total of 236 patients were included in the efficacy analysis. Diagnosis of vaginal candidosis was made at the start by a direct microscopic examination of a vaginal smear and was confirmed by culture. The majority of isolated yeasts were Candida albicans (97.6%). All three dose regimens resulted in clinical cure rates of over 75%, and these were maintained for at least 1 month after the end of treatment. There was a difference in mycological cure rates between the three dose schedules (71, 85 and 92%) 1 week after the end of therapy. In view of the clinical and mycological results both 1 week and 1 month after the end of treatment, it can be concluded that a total dose of 400 mg of saperconazole given in a single day is the optimum treatment schedule. All treatment regimens were well tolerated (adverse experiences occurred in 1.6% of the patients) and the results 1 month after termination of therapy suggest a low relapse rate.
Janssen Research Foundation, Beerse, Belgium.
K
K
De Beule
A
A
Dhondt
J
J
Van Cutsem
G
G
Cauwenbergh
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage*; D001393:Azoles / Q000008:administration & dosage*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008875:Middle Aged
D000935:Antifungal Agents; D001393:Azoles; C060571:saperconazole