scholarly journals Effect of butoconazole nitrate 2% vaginal cream and miconazole nitrate 2% vaginal cream treatments in patients with vulvovaginal candidiasis

Author(s):  
Myra A. Lappin ◽  
Doris C. Brooker ◽  
Carol A. Francisco ◽  
Joan Dorfman
1996 ◽  
Vol 4 (6) ◽  
pp. 323-328
Author(s):  
Myra A. Lappin ◽  
Doris C. Brooker ◽  
Carol A. Francisco ◽  
Joan Dorfman

In a multicenter, randomized, invesgtigator-blind, parallel study, 398 patients were dispensed topical butoconazole nitrate 2% cream for 3 days (n = 199) or miconazole nitrate 2% cream for 7 days (n = 199) for vaginal use. Efficacy analyses included 254 patients with culture-confirmedCandida(119 butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lost to follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazole users). Evaluations upon admission and approximately 8 and 30 days post-treatment includedCandidacultures, potassium hydroxide (KOH) wet mounts, and vulvovaginal examinations, with rating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based on sign/symptom scores), microbiologic cure (based on cultures and wet mounts), and therapeutic cure (both clinical and microbiologic cures) were assessed and were to be similar between the regimens. Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively. Three-day butoconazole treatment was as safe and effective as 7-day miconazole therapy in treating vulvovaginal candidiasis.


2005 ◽  
Vol 13 (4) ◽  
pp. 197-206 ◽  
Author(s):  
Larry S. Seidman ◽  
Campbell K. Skokos

Background.It is estimated that as many as 13 million cases of vulvovaginal infection occur in the United States annually, the majority of which are the result ofCandida albicansinfection. The symptoms of vulvovaginal infections are often painful and distressing to the patient. The objective of this study was to compare the time to symptomatic relief of vulvovaginal candidiasis (VVC) with butoconazole nitrate 2% Site Release®vaginal cream (Gynazole-1®) and oral fluconazole 150 mg tablets (Diflucan®).Methods.This randomized, open-label, parallel study evaluated 181 female patients with moderate to severe symptoms of VVC. Patients were randomized to single-dose therapy with either butoconazole nitrate 2% Site Release®vaginal cream or fluconazole. The primary outcome measure was the time to onset of first relief of symptoms. Secondary measures included the time to overall relief of symptoms and the reinfection rate over the first 30 days following treatment. The overall safety of both products was investigated through the collection of adverse event reports.Results.The median time to first relief of symptoms occurred at 17.5 h for butoconazole patients as compared to 22.9 h for fluconazole patients (p< 0.001). The time at which 75% of patients experienced first relief of symptoms was 24.5 h versus 46.3 h for butoconazole and fluconazole, respectively (p< 0.001). By 12- and 24-h post-treatment, 44.4% and 72.8% of patients in the butoconazole treatment group reported first relief of symptoms versus 29.1% and 55.7% of patients in the fluconazole group (p= 0.044 andp= 0.024 respectively). In patients experiencing first relief of symptoms within 48 h of dosing, the median time to first relief of symptoms in the butoconazole treatment group was significantly shorter at 12.9 h compared to 20.7 h for the fluconazole treatment group (p= 0.048). There were no significant differences between the two groups with respect to time to total relief of symptoms or reoccurrence of infection within 30 days of treatment. Butoconazole therapy was shown to have fewer reported adverse events, including drug-related adverse events, than fluconazole therapy. Vulvovaginal pruritis and vulvovaginal burning were the most common drug-related adverse events attributed to butoconazole. Headache, diarrhea, nausea, upset stomach and skin sensitivity were the most common drugrelated adverse events attributable to fluconazole.Conclusions.Single-dose butoconazole nitrate 2% Site Release®vaginal cream provides statistically significant improvement in time to first relief of symptoms in the treatment of VVC compared to fluconazole. There is no difference between these two treatments with respect to total relief of symptoms or reinfection rate. Although there was no significant difference in the incidence of adverse events judged by the investigator to be treatment-related, butoconazole treatment did result in fewer patients experiencing adverse events than fluconazole.


2019 ◽  
Vol 8 (12) ◽  
pp. 3920
Author(s):  
Zahra Abbaspoor ◽  
Nilufar Abouali ◽  
Eskandar Moghimipour ◽  
AliZarei Mahmoudabadi ◽  
Foroogh Namjouyan

2020 ◽  
Vol 3 (3) ◽  
pp. 205-210
Author(s):  
E.A. Markova ◽  

Recurrent vulvovaginal infections being an epidemiological and clinical issue also have social and psychological implications. As a result, the development of the effective diagnostic strategies and therapeutic approaches to female genital infections is important. This paper reviews the most common vulvovaginal infections, i.e., bacterial vaginosis and vulvovaginal candidiasis. Topical metronidazole and miconazole vaginal dosage forms prescribed for these relevant obstetrical gynecological disorders are highlighted. Although numerous domestic and foreign publications on the clinical efficacy of this combination are available, dose reductions and the minimum therapeutically effective doses for bacterial vaginosis, vulvovaginal candidiasis, and mixed vaginitis are still challenging entities. The data on the efficacy of a novel dosage form, Gynocaps® vaginal capsules, containing low doses of miconazole (100 mg) and metronidazole (100 mg) are addressed. The treatment has resulted in microbiological cleaning, the normalization of vaginal WBC count, and the improvement of vaginal florocenosis. In addition, easy-to-use vaginal capsules ensure treatment adherence.KEYWORDS: bacterial vaginosis, vulvovaginal candidiasis, metronidazole, miconazole nitrate, vaginal capsules.FOR CITATION: Markova E.A. Efficacy of metronidazole and miconazole vaginal co-formulation for bacterial vaginosis and vulvovaginal candidiasis. Russian Journal of Woman and Child Health. 2020;3(3):205–210. DOI: 10.32364/2618-8430-2020-3-3-205-210.


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