Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment

Study Overview
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Brief Summary
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In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).

Official Title
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Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: arasertaconazole nitrate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged between 18 to 65 years of age who have signed the informed consent. Not pregnant, not nursing. No indication of other vulvovaginitis or genital infections Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae. Negative wet mount results for T. vaginalis and clue cells. Exclusion Criteria: Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response. Hypersensitivity to imidazole products administered topically. Any other medical condition which in the opinion of the investigator could interfere with study conduct.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo pessary, single dose | Drug: arasertaconazole nitrate<br>* Arasertaconazole nitrate pessary, placebo pessary<br>|
| Experimental: Arasertaconazole nitrate 150 mg<br>Arasertaconazole nitrate 150 mg pessary, single dose | Drug: arasertaconazole nitrate<br>* Arasertaconazole nitrate pessary, placebo pessary<br>Drug: placebo<br>* placebo, single dose<br>|
| Experimental: arasertaconazole nitrate 300 mg<br>Arasertaconazole nitrate 300 mg pessary, single dose | Drug: arasertaconazole nitrate<br>* Arasertaconazole nitrate pessary, placebo pessary<br>Drug: placebo<br>* placebo, single dose<br>|
| Experimental: arasertaconazole 600 mg<br>Arasertaconazole nitrate 600 mg pessary, single dose | Drug: arasertaconazole nitrate<br>* Arasertaconazole nitrate pessary, placebo pessary<br>Drug: placebo<br>* placebo, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response of Clinical and Mycological (Global) Therapeutic Response | Global therapeutic response at day 26± 4 days (TOC- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline Vulvovaginal Candidiasis -Developing Antimicrobial Drugs for Treatment. | day 26 ± 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response of Clinical and Mycological (Global)Therapeutic Response | Global therapeutic response at day 8± 2 days. Safety and tolerability. | Day 8 ± 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VVC, candidiasis, vaginal candidiasis