title: 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.
abstract: To determine the efficacy and safety of a single-dose (1200 mg) soft gel insert (vaginal ovule) with miconazole nitrate (2%) topical cream compared with Monistat 7 (miconazole nitrate 2%) Vaginal Cream (Advanced Care Products, North Brunswick NJ) in treating vulvovaginal candidiasis (VVC), two randomized, single-blind, multicenter, controlled, comparative phase III studies were performed. Five hundred fifty-eight patients received either a single-dose miconazole nitrate (1200 mg) ovule or seven consecutive doses of Monistat 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 therapeutic cure. Also evaluated were time to complete symptom relief, safety, 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 rates of 70.1% (68 of 97 patients) and 61.1% (55 of 90 patients). A significantly 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 relief was significantly faster (median 4 versus 5 days and 3 versus 4 days). Overall safety results were consistent between groups in both studies. Miconazole nitrate vaginal ovule is as safe and efficacious in curing VVC as Monistat 7 while providing complete symptom relief significantly faster. Patients preferred the ovule to prior therapy.
authors.affiliation: Department of Clinical Affairs, Advanced Care Products, North Brunswick, New Jersey 08902, USA.
authors.forename: D H
authors.initials: DH
authors.lastname: Upmalis
authors.forename: F L
authors.initials: FL
authors.lastname: Cone
authors.forename: C A
authors.initials: CA
authors.lastname: Lamia
authors.forename: H
authors.initials: H
authors.lastname: Reisman
authors.forename: G
authors.initials: G
authors.lastname: Rodriguez-Gomez
authors.forename: L
authors.initials: L
authors.lastname: Gilderman
authors.forename: L
authors.initials: L
authors.lastname: Bradley
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D002626:Chemistry, Pharmaceutical; D005260:Female; D006801:Humans; D008825:Miconazole / Q000008:administration & dosage*; D008875:Middle Aged; D017060:Patient Satisfaction; D016037:Single-Blind Method; D013020:South America; D016896:Treatment Outcome; D014481:United States; D014622:Vaginal Creams, Foams, and Jellies
chemical_list: D000935:Antifungal Agents; D014622:Vaginal Creams, Foams, and Jellies; D008825:Miconazole