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

Ferrer Internacional S.A.229 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

229

Conditions

Vulvovaginal Candidiasis

Interventions

arasertaconazole nitrateDRUG

Arasertaconazole nitrate pessary, placebo pessary

placeboDRUG

placebo, single dose

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ferrer Internacional S.A.

Barcelona, Spain

Outcomes

Primary Outcomes

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".

Time frame: day 26 ± 4 days

Secondary Outcomes

Dose-response of Clinical and Mycological (Global)Therapeutic Response

Global therapeutic response at day 8± 2 days. Safety and tolerability.

Time frame: Day 8 ± 2 days

Data from ClinicalTrials.gov

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