A Phase II, Randomized, Parallel design, Open label, Dose ranging Study to evaluate the efficacy and safety of Furazidin vaginal tablets in women with bacterial vaginosis

INTERVENTION: Product Name: Furazidin, vaginal tablets, 5 mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Name: Furazidin, vaginal tablets, 25mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Product Name: Furazidin, vaginal tablets, 50mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Product Name: Furazidin, vaginal tablets, 100mg Pharmaceutical Form: Vaginal tablet INN or Proposed INN: Furazidin CAS Number: 1672‐88‐4 Other descriptive name: FURAZIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Dalacin 2% Vaginal Cream Product Name: Dalacin 2% Vaginal Cream Pharmaceutical Form: Vaginal cream INN or Proposed INN: clindamycin phosphate CAS Number: 24729‐96‐2 Other descriptive name: CLINDAMYCIN PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Bacterial Vaginosis (BV) ; MedDRA version: 20.1 Level: PT Classification code 10004055 Term: Bacterial vaginosis System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] SECONDARY OUTCOME: Secondary end point(s): 1. Day 5 assessment of clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test as well as greyish white, malodorous discharge), where clinical cure is defined as: the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount.; 2. Percentage of subjects with Nugent score of less than 4 (Day 21‐30); 3. Percentage of responders with outcome defined as a clinical cure plus Nugent score of less than 4 (Day 21‐30); 4. Assessment of patient quality of life with 5 treatments modalities (from the baseline visit to the end of the treatment); 5. Assessment of the patients’ compliance; 6. The percentage of Bacterial Vaginosis recurrences within 12 weeks of follow‐up; Timepoint(s) of evaluation of this end point: Day 5 PRIMARY OUTCOME: Main Objective: To evaluate the safety and efficacy of Furazidin vaginal tablets in patients with Bacterial Vaginosis.; To perform a proof of concept study to establish the most appropriate dosage (dosage regimen and treatment duration) to take forth into a phase III trial. Four different doses of study drugs as well as the comparator (Clindamycin cream 2%) will be applied vaginally to adult women with clinical signs and symptoms of vaginal infections caused by Bacteria spp.; In addition, the safety and local tolerability of four tested doses of the study drug will be assessed.; Primary end point(s): 1. Safety and local tolerability – incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated to IMP.; Safety and local tolerability assessment based on Likert scale of the signs/symptoms:; • Assessed by physician:; Verbal evaluation of local symptoms and naked eye inspection of visible epithelial surface will be performed. Patients will be questioned and clinician will verify the following symptomps according to the Likert like scale (NO, MILD, MODERATE, MODERATE TO SEVERE, SEVERE):; o Discharge (normal/abnormal); o Dysuria; o Irritation; o Puffiness ; o Hyperemia of the mucosa ; ; • Reported by patient; Self‐reporting evaluations will be performed by patients according to the Likert like scale (NO, MILD, MODERATE, MODERATE TO SEVERE, SEVERE):; o Burning; o Discharge (normal/abnormal); o Dysuria; o Discomfort; o Irritation; o Itching; o Pain; ; 2. Clinical endpoint – the Day 8 assessment of clinical cure rate based on the Amsel criteria (vaginal pH > 4.5, presence of clue cells, KOH test as well as greyish white, malodorous discharge), where clinical cure is defined as: the resolution of the abnormal vaginal discharge, a negative whiff test, and the presence of clue cells at less than 20% of the total epithelial cells on microscopic examination of the saline wet mount. Secondary Objective: not applicable Timepoint(s) of evaluation of this end point: Day 8 INCLUSION CRITERIA: 1. A written informed consent signed before any study‐specific evaluation is performed. 2. Female patients with age = 18 and = 50 years. 3. Patients requiring treatment for bacterial vaginosis. 4. Papanicolaou (Pap) smear/tests will be performed for subjects who do not have a negative test for intraepithelial lesion or malignancy or atypical squamous cells of undetermined significance in the past 24 months; in circumstances where the results of the Pap smear are pending at the time of randomization, eligible subjects may be randomized. 5. Women 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 (up to Follow Up Visit 4 – Day 21‐30). 6. Agreement of female subject of childbearing potential to use highly effective methods of contraception (progestin intrauterine device, all oral contraceptives, transdermal hormonal contraceptives) or to a