Butoconazole nitrate 2% for vulvovaginal candidiasis - New, single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate

OBJECTIVE: To compare the safety and efficacy of a single vaginal dose of a butoconazole nitrate 2% bioadhesive, sustained-release cream* (butoconazol e 1-BSR) with a seven-day schedule of miconazole nitrate vaginal cream 2% ( miconazole 7). STUDY DESIGN: The clinical trial was conducted according to a randomized, p arallel, investigator-blind, multicenter study design. The patients self-ad ministered the respective creams to the posterior vaginal fornix. Two hundr ed twenty-three patients started the trial and were analyzed for safety. A total of 205 patients qualified fro efficacy analysis, 101 receiving butoco nazole 1-BSR and 104 using miconazole 7. Patients receiving butoconazole 1- BSR inserted one applicator full of medication once. Those assigned to rece ive miconazole 7 inserted one applicator full daily for seven days. Patient s were evaluated 7-10 and 30 days after completion of therapy. RESULTS: Butoconazole 1-BSR rapidly relieved the signs and symptoms of vulv ovaginal candidiasis. The proportion of patients with severe symptoms decli ned from the pretreatment 20% to 6% on the Ist day, to 3% on the 4th day, a nd to 2-1% on the 5th-7th day after single-dose application. Eight to ten c lays after treatment completion, clinical symptoms regressed in 92%, and fu ngal cultures were negative in 87% of patients. At the 30-day posttreatment visit, 88% of patients remained clinically cured, and 74% had negative-fun gal cultures. In the miconazole 7 group, the proportion of patients with se vere symptoms declined from 23% to 19% after the first dose; thereafter, sy mptom relief proceeded more rapidly. Eight to ten days after treatment comp letion, clinical symptoms regressed in 92% and fungal cultures were negativ e in 87% of patients. At the 30-day follow-up examination 86% patients were clinically cured, and 77% were culture negative. After single-dose butocon azole 1-BSR, severe symptoms receded faster than after the first nose of mi conazole 7, and the difference was statistically significant (P=.01). In al l other efficacy parameters, the differences between the two groups were no t statistically significant. Neither treatment regimen caused significant a dverse events. CONCLUSION: This clinical trial demonstrated that butoconazole 1-BSR is an effective and safe alternative to longer-term therapy with miconazole nitra te (seven days) for vulvovaginal candidiasis.