Register for Two-day regimen of fenticonazole nitrate studied as first-line treatment
VulvovaginitisAugust 19, 2004
2004 AUG 19 - (NewsRx.com & NewsRx.net) -- Results of a small pilot study suggest a short, 2-day regimen of fenticonazole nitrate (1 g vaginal ovules) might be an effective first-line treatment for vulvovaginitis.
"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," explained J. Fernandez-Alba, Mexico City, Mexico, and colleagues.
"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<.001); 70% (T. vaginalis, 7/10, p=.161); 67% (G. vaginalis, 22/33, p<.009); and 45% (mixed infection, 13/29, p=.001)," the researchers reported.
"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<.001)," Fernandez-Alba and team wrote.
They also noted the "treatment was safe and well tolerated."
The researchers concluded, "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."
Fernandez-Alba and coauthors published their findings in the Journal of Chemotherapy (Fenticonazole nitrate for treatment of vulvovaginitis: Efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen. J Chemotherapy, 2004;16(2):179-186).
Additional information can be obtained by contacting J. Fernandez-Alba, 8-PB, Col Anzures, Mexico City 11590, DF, Mexico.
The publisher of the Journal of Chemotherapy can be contacted at: EIFT Srl, Via XX Settembre 102, 50129 Florence, Italy.
The information in this article comes under the major subject areas of Gynecology, Vulvovaginitis, Therapy, and Women's Health. This article was prepared by Women's Health Weekly editors from staff and other reports. Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net.
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