Butoconazole Nitrate Vaginal Cream

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.

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Effect of Butoconazole Nitrate 2% Vaginal Cream and Miconazole Nitrate 2% Vaginal Cream Treatments in Patients with Vulvovaginal Candidiasis

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/s1064744996000658 ◽

1996 ◽

Vol 4 (6) ◽

pp. 323-328

Author(s):

Myra A. Lappin ◽

Doris C. Brooker ◽

Carol A. Francisco ◽

Joan Dorfman

Keyword(s):

Potassium Hydroxide ◽

Signs And Symptoms ◽

Vulvovaginal Candidiasis ◽

Vaginal Cream ◽

Miconazole Nitrate ◽

Symptom Scores ◽

Cure Rates ◽

Lost To Follow Up ◽

Butoconazole Nitrate

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.

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

Infectious Diseases in Obstetrics and Gynecology ◽

10.1002/(sici)1098-0997(1996)4:6<323::aid-idog5>3.0.co;2-x ◽

1996 ◽

Vol 4 (6) ◽

pp. 323-328

Author(s):

Myra A. Lappin ◽

Doris C. Brooker ◽

Carol A. Francisco ◽

Joan Dorfman

Keyword(s):

Vulvovaginal Candidiasis ◽

Vaginal Cream ◽

Miconazole Nitrate ◽

Butoconazole Nitrate

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Comparison of the Effects of Fenugreek Vaginal Cream and Ultra Low- Dose Estrogen on Atrophic Vaginitis

Current Drug Delivery ◽

10.2174/1567201817666200708112655 ◽

2020 ◽

Vol 17 (9) ◽

pp. 815-822

Author(s):

Maryam Safary ◽

Sevil Hakimi ◽

Noushin Mobaraki-Asl ◽

Paria Amiri ◽

Habib Tvassoli ◽

...

Keyword(s):

Postmenopausal Women ◽

Low Dose ◽

Intervention Group ◽

Clinical Signs ◽

Control Group ◽

Conjugated Estrogens ◽

Atrophic Vaginitis ◽

Vaginal Cream ◽

Intergroup Comparison ◽

Significant Difference

Introduction: Atrophic vaginitis is a common problem in postmenopausal women and results from decreased levels of blood estrogen. It is associated with symptoms of itching, burning, dyspareunia, and postmenopausal bleeding. The present study evaluated the effects of fenugreek extract on atrophic vaginitis. Materials and Methods: This randomized controlled clinical trial was performed on 60 postmenopausal women in Ardabil, Iran, in 2018. The participants were selected using block randomization with the allocation ratio 1:1. Those in the intervention group received 0.5g (the applicator filled to the half-full mark) fenugreek vaginal cream 5% twice a week for 12 weeks. The control group received conjugated estrogens vaginal cream at the dose of 0.625 mg (the applicator filled to the half-full mark) containing 0.3 mg of conjugated estrogens. Atrophic vaginitis was evaluated before and after the treatment through clinical examination, clinical signs, and measurement of Vaginal Maturation Index (VMI). Findings: After the 12-week intervention and modification of the baseline score, the mean (standard error) score for atrophic vaginitis signs was 3.100 (1.43-4.75). This difference was statistically significant in intragroup comparison and in favor of the control group in intergroup comparison (p=0.001). VMI was less than 49% in 86.7% and 46.7% of the participants in the intervention and control groups, respectively. This was a significant difference in favor of the control group (p=0.001). Conclusion: The results of this study showed that total fenugreek extract could be effective in treating signs of atrophic vaginitis, but it was not as effective as ultra-low-dose estrogen.

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Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study

Journal of International Medical Research ◽

10.1177/03000605211013226 ◽

2021 ◽

Vol 49 (5) ◽

pp. 030006052110132

Author(s):

Ana Rosa Masero ◽

Luís Manuel San Frutos ◽

Ernesto Vizcaíno ◽

María Palma ◽

Syra Velasco-Ortega ◽

...

Keyword(s):

Antimicrobial Therapy ◽

Vaginal Discharge ◽

Signs And Symptoms ◽

Controlled Trials ◽

Adult Women ◽

Global Score ◽

Point Scale ◽

Vaginal Cream ◽

Before And After ◽

Larger Sample

Objective To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV). Methods This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score). Results The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability. Conclusions Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted.

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