Table 4.
Randomized controlled studies investigating intravaginal clotrimazole in women with recurrent symptomatic vulvovaginal candidosis.
| Reference and Population | Design | Fungal Verification Method | Candida Species | Drug and Formulation | Regimen | Outcomes | Adverse Events |
|---|---|---|---|---|---|---|---|
| [71] Adults |
r, db, pc | Culture and microscopy |
C. albicans (86% of subjects) |
CLO vaginal suppository or placebo |
Phase 1 (Rx) (all subjects) CLO: 500 mg qw for 2 w, n = 42 Phase 2 (Pro) * CLO: 500 mg qm for 6 m, n = 15 Placebo: n = 12 |
Phase 1 Mycological cure rate at W 2 after Rx: 83% Clinical cure rate at W 2 after Rx: 90% Phase 2 Mycologically still cured at M 6 (CLO vs. placebo): ~20% # vs. ~5% #, ns Clinically still cured at M 6 (CLO vs. placebo): 47% vs. 33%, ns |
None occurred |
| [72] Adults |
r, db, pc | Culture and microscopy | C. albicans | CLO vaginal tablet or placebo | Phase 1 (Rx) (all subjects) CLO: 500 mg, single dose Phase 2 (Pro) $ CLO: 500 mg qm for 6 m, n = 33 Placebo: n = 29 |
Phase 1 Mycological and clinical cure rates: nr Phase 2 Mycologically still cured at M 6 (CLO vs. placebo): 30% vs. 14%, ns Clinically still cured at M 6 (CLO vs. placebo): 70% vs. 21%, p < 0.001 |
None occurred |
| [73] Adults |
r, o, ac | Culture and microscopy | C. albicans | CLO vaginal ovules or oral itraconazole | CLO: 200 mg qd for 5 d, then 200 mg biw for 6 m, n = 22 Itraconazole: 100 mg bid for 5 d, then 200 mg biw for 6 m, n = 22 |
Mycological + clinical cure rate at M 6 after Rx (CLO vs. itraconazole): 17/17 (100%) vs. 14/21 (67%), p = 0.02 | Itraconazole: 32% of subjects had mild AEs |
| [69] Adults |
r, o, mc | Culture and microscopy | nr | CLO vaginal suppository or oral ketoconazole | CLO: 100 mg qd for 7 d, n = 77 Ketoconazole: 400 mg qd for 14 d, n = 74 No maintenance treatment in both groups |
Mycological cure rate at W 1 after Rx (CLO vs. ketoconazole): 82% vs. 80%, ns Clinical cure rate at W 1 after Rx (CLO vs. ketoconazole): 82% vs. 86%, ns Clinical cure rate at M 2 after Rx (CLO vs. ketoconazole): 37% vs. 48%, ns |
AEs occurred significantly more frequently with ketoconazole CLO: 3.1% had mild vulvovaginal burning |
ac: active-controlled; AEs: adverse events; bid: twice-daily; biw: twice-weekly; CLO: clotrimazole; d or D: day; db: double-blind; mc: multicenter; m or M: month; n: number of subjects; nr: not reported; ns: not statistically significant; o: open; pc: placebo-controlled; Pro: prophylaxis; qd: once-daily; qw: once-weekly; qm: once-monthly; r: randomized; Rx: treatment; w or W: week. * Only asymptomatic women, culture status was ignored; # Estimated from graphical display; $ Only asymptomatic women with negative microscopy and culture.