Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of different doses of Venus association in the treatment of vulvovaginal candidiasis.

Official Title
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National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Venus 20 + 0,064
* Drug: Venus 20 + 1
* Drug: Venus 20 + 4
* Drug: Butoconazole nitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; Age greater than or equal to 18 years; Female participants, post-menarche; Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings: Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation; Normal vaginal pH; Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast. Exclusion Criteria: Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; Participation in a clinical trial in the year prior to this study; Pregnancy or risk of pregnancy and lactating patients; Known hypersensitivity to any of the formula compounds; Virgin participants; Postmenopausal participants or with vaginal atrophy; Participants with other vaginal infections; Participants with recurrent vulvovaginal candidiasis; Participants using immunosuppressive drugs; Participants diagnosed with serious systemic diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VENUS 20 + 0,064<br>Venus association vaginal cream, single dose. | Drug: Venus 20 + 0,064<br>* Venus vaginal cream 20 + 0,064, single-dose.<br>|
| Experimental: VENUS 20 + 1<br>Venus association vaginal cream, single dose. | Drug: Venus 20 + 1<br>* Venus vaginal cream 20 + 1, single-dose.<br>|
| Experimental: VENUS 20 + 4<br>Venus association vaginal cream, single dose. | Drug: Venus 20 + 4<br>* Venus vaginal cream 20 + 4, single-dose.<br>|
| Active Comparator: Butoconazole nitrate 100 mg<br>Butoconazole nitrate vaginal cream, single-dose containing 100 mg. | Drug: Butoconazole nitrate<br>* Butoconazole nitrate vaginal cream, 100 mg single-dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first relief of symptoms | Time to obtain moderate relief of at least one of the evaluated symptoms (itching, irritation or burning) after the application of the medication. | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and severity of adverse events recorded during the study. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvovaginal Candidiasis