Single-dose miconazole nitrate vaginal ovule in the treatment of vulvovaginal candidiasis: Two single-blind, controlled studies versus miconazole nitrate 100 mg cream for 7 days

To determine the efficacy and safety of a single-dose (1200 mg) soft gel in sert (vaginal ovule) with miconazole nitrate (2%) topical cream compared wi th Monistat(R)7 (miconazole nitrate 2%) Vaginal Cream (Advanced Care Produc ts, North Brunswick NJ) in treating vulvovaginal candidiasis (VVC), two ran domized, single-blind, multicenter, controlled, comparative phase III studi es were performed. Five hundred fifty-eight patients received either a sing le-dose miconazole nitrate (1200 mg) ovule or seven consecutive doses of Mo nistat 7. Ovule arm patients also received miconazole nitrate 2% cream for symptom relief, as needed, up to twice daily. The primary end point was a t herapeutic cure. Also evaluated were time to complete symptom relief, safet y, and patient preference. The ovule had overall cure rates of 71.7% (71 of 99 patients) and 61.5% (64 of 104 patients). Monistat 7 had overall cure r ates of 70.1% (68 of 97 patients) and 61.1% (55 of 90 patients). A signific antly greater proportion of patients experienced complete symptom relief by day 3 with the ovule (p = 0.008 and p = 0.025), and time to complete relie f was significantly faster (median 4 versus 5 days and 3 versus 4 days). Ov erall safety results were consistent between groups in both studies. Micona zole nitrate vaginal ovule is as safe and efficacious in curing VVC as Moni stat 7 while providing complete symptom relief significantly faster. Patien ts preferred the ovule to prior therapy.