title: Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen.
abstract: 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.
authors.affiliation: Escuela de Medicina de la Universidad Anahuac, Mexico. jufernan@anahuac.mx
authors.forename: J
authors.initials: J
authors.lastname: Fernández-Alba
authors.forename: A
authors.initials: A
authors.lastname: Valle-Gay
authors.forename: M
authors.initials: M
authors.lastname: Dibildox
authors.forename: J A
authors.initials: JA
authors.lastname: Vargas
authors.forename: J
authors.initials: J
authors.lastname: González
authors.forename: M
authors.initials: M
authors.lastname: García
authors.forename: L H
authors.initials: LH
authors.lastname: López
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy / Q000382:microbiology / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome; D014848:Vulvovaginitis / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology
chemical_list: D000935:Antifungal Agents; D007093:Imidazoles; C033486:fenticonazole