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

INTERVENTION: Product Name: Miconazole Nitrate Pharmaceutical Form: Vaginal cream INN or Proposed INN: DOMIPHEN BROMIDE CAS Number: 538‐71‐6 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.14‐ Trade Name: Gyno‐Daktarin Pharmaceutical Form: Vaginal cream Product Name: Miconazole Nitrate Pharmaceutical Form: Vaginal cream INN or Proposed INN: DOMIPHEN BROMIDE CAS Number: 538‐71‐6 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.29‐ CONDITION: acute vulvovaginal candidiasis Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: The primary objectives of this study are to evaluate the efficacy of vaginal miconazole nitrate 2% + domiphen bromide cream in the treatment of VVC compared to miconazole nitrate 2% based on the cure rate of VVC at Day 15, and to determine the most optimal dose of domiphen bromide (0.14% or 0.29%) for the treatment of VVC through Week 12.; Primary end point(s): Primary efficacy endpoints :; •The proportion of subjects with clinical cure at the first follow‐up visit (Day 15); •The proportion of subjects with mycological eradication at the first follow‐up visit (Day 15); •The proportion of subjects with overall therapeutic success at the first follow‐up visit (Day 15); Secondary Objective: The secondary objectives of this study are to:; •Evaluate the safety and tolerability of the two formulations of vaginal miconazole nitrate + domiphen bromide cream through Week 12.; •Evaluate the efficacy of vaginal miconazole nitrate + domiphen bromide cream in the treatment of VVC compared to miconazole nitrate 2% based on the cure rate of VVC at Day 29, Day 57 and Day 85.; •Evaluate the efficacy of the two formulations of vaginal miconazole nitrate + domiphen bromide treatment on patient reported outcomes through Week 12. ; Timepoint(s) of evaluation of this end point: Day 15 SECONDARY OUTCOME: Secondary end point(s): Secondary efficacy endpoints :; • The proportion of subjects with clinical cure at the first follow‐up visit through Week 12.; • The proportion of subjects with mycological eradication at the first follow‐up visit through Week 12.; • The proportion of subjects with overall therapeutic success (defined as clinical cure and mycological eradication) through Week 12.; • Change from Baseline through Week 12 in vulvovaginitis symptom questionnaire total score.; • Change from Baseline through Week 12 in the EQ‐5D questionnaire total score.; Secondary safety endpoints :; • Change from Baseline in clinical laboratory parameters on Follow‐Up Visits; (Serum chemistry, hematology and urinalysis through Week 12); • Frequency and severity of Adverse Events during treatment period as well as post‐treatment (AEs); • Change from Baseline in vital signs on Follow‐Up Visits through Week 12 Timepoint(s) of evaluation of this end point: through Week 12, including follow‐up visits on Day 15, Day 29, Day 57 and Day 85 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. Subjects of childbearing potential must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period. Subjects of childbearing potential must agree to use highly effective methods of contraception or to abstain from sexual intercourse. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range