A Multi-Centre, 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 Vulvovaginal Candidiasis

INTERVENTION: Product Name: Arasertaconazole nitrate Product Code: GF‐001574‐43 Pharmaceutical Form: Pessary INN or Proposed INN: Arasertaconazole nitrate CAS Number: 583057‐49‐2 Current Sponsor code: Arasertaconazole nitrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Pessary Route of administration of the placebo: Vaginal use Product Name: Arasertaconazole nitrate Product Code: GF‐001574‐43 Pharmaceutical Form: Pessary INN or Proposed INN: Arasertaconazole nitrate CAS Number: 583057‐49‐2 Current Sponsor code: Arasertaconazole nitrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Pharmaceutical form of the placebo: Pessary Route of administration of the placebo: Vaginal use Product Name: Arasertaconazole nitrate Product Code: GF‐001574‐43 Pharmaceutical Form: Pessary INN or Proposed INN: Arasertaconazole nitrate CAS Number: 583057‐49‐2 Current Sponsor code: Arasertaconazole nitrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Pessary Route of administration of the placebo: Vaginal use CONDITION: Vulvovaginal Candidiasis ; MedDRA version: 12.1 Level: PT Classification code 10047784 Term: Vulvovaginal candidiasis PRIMARY OUTCOME: Main Objective: The primary objective is to determine the dose response of arasertaconazole nitrate in the treatment of VVC for Phase III clinical studies. Primary end point(s): Efficacy; • The primary efficacy endpoint for this study is the dose response for global therapeutic cure at the TOC (Visit 3).; ; Safety; • Adverse events (systemic and local); • Change from baseline in physical examination at Visits 2 and 3 ; • Change from baseline in vital signs (systolic/diastolic blood pressure and heart rate) at Visits 2 and 3. ; • Change from baseline in ECG at Visits 2 and 3; • Change from baseline in laboratory tests (hematology, biochemistry, urinalysis and coagulation tests) at Visit 2; Secondary Objective: The secondary objective of this study is to determine the safety and tolerability of the 3 different tested doses of arasertaconazole nitrate pessaries. INCLUSION CRITERIA: 1. Women with VVC who are exhibiting at least 2 of the following clinical signs and symptoms of disease: itching, burning, irritation, edema, erythema, excoriation of the vagina, with a total score of 5 or greater (0=absent, 1=mild, 2=moderate, and 3=severe). 2. Women aged between 18 to 65 years of age who have signed the informed consent. 3. Expected menstruation period not before Day 6. 4. Not pregnant, not nursing or at least 1‐year post menopausal or subjects who underwent surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). 5. Subjects must have agreed to practice sexual abstinence for at least Visit 2 (Day 8 ± 2 days). 6. From Visit 2 to Visit 3 subjects must agree to use a condom in case of sexual intercourse. 7. After Visit 2 until Visit 3 (Day 26 ± 4 days, Test‐of‐Cure [TOC] Visit), the subject must agree to use or continuing use at least one of the contraceptive methods to be defined as: • ab