Phase II trial: an evaluation of oral saperconazole in acute vaginal candidosis: a comparison of three dosage schedules

Eur J Obstet Gynecol Reprod Biol. 1991 Oct 8;41(3):231-6. doi: 10.1016/0028-2243(91)90029-k.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Antifungal Agents / administration & dosage*
  • Azoles / administration & dosage*
  • Candidiasis, Vulvovaginal / drug therapy*
  • Drug Administration Schedule
  • Drug Evaluation
  • Female
  • Humans
  • Middle Aged

Substances

  • Antifungal Agents
  • Azoles
  • saperconazole