A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

Study Overview
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Brief Summary
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This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.

Official Title
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A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Butoconazole Nitrate Vaginal Cream
* Drug: Placebo
* Drug: Gynazole 1 vaginal cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects, at least 18 years of age Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis Signed and dated informed consent Exclusion Criteria: Were pregnant, nursing, or planning a pregnancy within the study participation period Had evidence of any bacterial, viral, or protozoal infection Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>vehicle of the test product; applied intravaginally once within 48 hours of randomization | Drug: Placebo<br>* vaginal cream<br>* Other names: vehicle of the test product;|
| Experimental: Test Product<br>Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization | Drug: Butoconazole Nitrate Vaginal Cream<br>* vaginal cream<br>|
| Active Comparator: Reference Product<br>Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization | Drug: Gynazole 1 vaginal cream<br>* vaginal cream<br>* Other names: Gynazole 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure) | Visit 3: Day 22-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | Clinical cure (clinical success) was defined as follows: All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure) The subject did not require additional vulvovaginal or systemic antifungal therapy The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products | Visit 3: Day 22-31 | 
| Mycological Cure | Mycological cure was defined as a negative mycological culture (no growth) | Visit 3: Day 22-31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, butoconazole, vulvovaginal, candidiasis