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: D H Upmalis, F L Cone, C A Lamia, H Reisman, G Rodriguez-Gomez, L Gilderman, L Bradley
• Journal: Journal of women's health & gender-based medicine (J Womens Health Gend Based Med) Vol. 9 Issue 4 Pg. 421-9 (May 2000) ISSN: 1524-6094 [Print] United States
• PMID: 10868615 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Vaginal Creams, Foams, and Jellies
• Miconazole

Topics

• Administration, Intravaginal
• Adolescent
• Adult
• Aged
• Antifungal Agents (administration & dosage)
• Candidiasis, Vulvovaginal (drug therapy)
• Chemistry, Pharmaceutical
• Female
• Humans
• Miconazole (administration & dosage)
• Middle Aged
• Patient Satisfaction
• Single-Blind Method
• South America
• Treatment Outcome
• United States
• Vaginal Creams, Foams, and Jellies