Because of its potential as a low cost first-line monotherapy for the most common vulvovaginal
infections, we evaluated
fenticonazole nitrate in a prospective, open-label, multicenter pilot study with 101 sexually active women (per-protocol; 16 to 61 years of age) with
vulvovaginitis involving single or
mixed infections with Candida albicans, Trichomonas vaginalis, and/or Gardnerella vaginalis.
Fenticonazole nitrate (1 g) was administered as vaginal ovules, once daily on days 1 and 3. Eradication (direct phase-contrast microscopy of vaginal swabs and/or microbiological culture) on day 8 was 90% (C. albicans, 26/29, p < 0.001), 70% (T. vaginalis, 7/10, p = 0.161), 67% (G. vaginalis, 22/33, p < 0.009), and 45% (
mixed infection, 13/29, p = 0.001). After 28 days, relapse was 0% for
candidiasis and
trichomoniasis, 27% (6/22) for G. vaginalis, and 23% (3/13) for
mixed infection. Overall, eradication of all offending pathogens was achieved in 67% of the total per-protocol population, with a relapse rate of only 16%. Score sums for symptoms improved from 7.0 (baseline) to 1.7 (day 8), and 0.71 (day 28), (p < 0.001). Treatment was safe and well tolerated. The results of our pilot study suggest that application of
fenticonazole nitrate 1 g intravaginal ovules on 2 alternate days is a suitable first-line treatment of
vulvovaginitis with acceptable broad-spectrum efficacy against the most commonly involved pathogens and with a low rate of early relapse, reserving
antibiotics for patients with treatment failure or relapse of
infection. Our results should encourage further examination of this approach in larger and well controlled clinical trials.