Butoconazole nitrate 2% for vulvovaginal candidiasis. New, single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate. Gynazole 1 Study Group.
OBJECTIVE
To compare the safety and efficacy of a single vaginal dose of a butoconazole nitrate 2% bioadhesive, sustained-release cream* (butoconazole 1-BSR) with a seven-day schedule of miconazole nitrate vaginal cream 2% (miconazole 7).


METHODS
The clinical trial was conducted according to a randomized, parallel, investigator-blind, multicenter study design. The patients self-administered the respective creams to the posterior vaginal fornix. Two hundred twenty-three patients started the trial and were analyzed for safety. A total of 205 patients qualified for efficacy analysis, 101 receiving butoconazole 1-BSR and 104 using miconazole 7. Patients receiving butoconazole 1-BSR inserted one applicator full of medication once. Those assigned to receive miconazole 7 inserted one applicator full daily for seven days. Patients were evaluated 7-10 and 30 days after completion of therapy.


RESULTS
Butoconazole 1-BSR rapidly relieved the signs and symptoms of vulvovaginal candidiasis. The proportion of patients with severe symptoms declined from the pretreatment 20% to 6% on the 1st day, to 3% on the 4th day, and to 2-1% on the 5th-7th day after single-dose application. Eight to ten days after treatment completion, clinical symptoms regressed in 92%, and fungal cultures were negative in 87% of patients. At the 30-day posttreatment visit, 88% of patients remained clinically cured, and 74% had negative fungal cultures. In the miconazole 7 group, the proportion of patients with severe symptoms declined from 23% to 19% after the first dose; thereafter, symptom relief proceeded more rapidly. Eight to ten days after treatment completion, clinical symptoms regressed in 92% and fungal cultures were negative in 87% of patients. At the 30-day follow-up examination, 86% patients were clinically cured, and 77% were culture negative. After single-dose butoconazole 1-BSR, severe symptoms receded faster than after the first dose of miconazole 7, and the difference was statistically significant (P = .01). In all other efficacy parameters, the differences between the two groups were not statistically significant. Neither treatment regimen caused significant adverse events.


CONCLUSIONS
This clinical trial demonstrated that butoconazole 1-BSR is an effective and safe alternative to longer-term therapy with miconazole nitrate (seven days) for vulvovaginal candidiasis.
Brown
D
D
Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas, USA.
Henzl
M R
MR
Kaufman
R H
RH
D000287:Administration, Topical; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008825:Miconazole / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000935:Antifungal Agents; D007093:Imidazoles; C017125:butoconazole; D008825:Miconazole