Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

Study Overview
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Brief Summary
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This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

Detailed Description
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Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.

Official Title
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A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

Conditions
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Acute Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose
* Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose
* Drug: Miconazole Nitrate 2%


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit. Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells. Main exclusion criteria : Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment. Subjects with visible condylomas on vulvovaginal examination at Screening Visit. Subjects with the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of the clinical response. Subjects with a history of cervical cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream<br>The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. | Drug: Miconazole Nitrate 2% + Domiphen Bromide Low Dose<br>* Dosage 1<br>|
| Experimental: Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream<br>The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. | Drug: Miconazole Nitrate 2% + Domiphen Bromide High Dose<br>* Dosage 2<br>|
| Active Comparator: Gyno-Daktarin® Vaginal Cream<br>The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. | Drug: Miconazole Nitrate 2%<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with clinical cure | Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline) | First follow-up visit (Day 15) | 
| The proportion of subjects with mycological eradication | A culture negative vaginal swab for growth of baseline Candida species | First follow-up visit (Day 15) | 
| The proportion of subjects with overall therapeutic success | Achievement of both clinical cure and mycological eradication | First follow-up visit (Day 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with clinical cure | Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline) | First follow-up visit through Week 12 | 
| The proportion of subjects with mycological eradication | A culture negative vaginal swab for growth of baseline Candida species at Day 15, a culture and PCR negative vaginal swab for growth of baseline Candida species on the Other follow-up visits | First follow-up visit through Week 12 | 
| The proportion of subjects with overall therapeutic success | Achievement of both clinical cure and mycological eradication | First follow-up visit through Week 12 | 
| Change from Baseline in vulvovaginitis symptom questionnaire total score | VSQ: Vulvovaginal symptoms questionnaire | Through Week 12 | 
| Change from Baseline in the EQ-5D questionnaire total score | EQ-5D: health-related quality of life questionnaire | Through Week 12 |