Open Studies of the Efficacy, Tolerance, Systemic Absorption and Vaginal Persistence following a Single Application of Tioconazole Ointment in the Treatment of Patients with Vaginal Candidiasis
A total of 40 patients took part in two open studies to assess the efficacy, tolerance, systemic absorption and vaginal persistence following a single application of tioconazole 6% ointment (300 mg tioconazole in 5 ml ointment) in the treatment of vaginal candidiasis. At the first review (3–11 days after treatment) 35 of 39 patients (90%) were clinically and mycologically cured. Of these 35 patients cured at first review, 26 were seen at follow-up (26–46 days after treatment); 17 (65%) of this group remained cured. 4 patients reported mild local burning on the day of application. The ointment was administered by the investigator, who found the method of application satisfactory in all patients. Although some leakage of ointment from the vagina was reported by all patients, the amount was considered acceptable. No staining of clothing was reported. Small amounts of tioconazole were detected in the plasma of 9 of the 10 patients. The mean of the peak levels in these 9 patients was 18 ng/ml (range 10–35 ng/ml) and the mode time to attain peak concentrations was 8 h. Tioconazole was detectable in the plasma of only 1 patient 72 h after application. 24 h after a single intravaginal application of tioconazole, the mean concentration of tioconazole in vaginal fluid exudate was 104 mg/l (range 1–238 mg/l).