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
Dh. Upmalis et al., 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, J WOMEN H G, 9(4), 2000, pp. 421-429
Citations number
10
Categorie Soggetti
Public Health & Health Care Science","General & Internal Medicine
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.