Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis

Study Overview
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Brief Summary
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The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis. Vaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US. The broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus. In addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina. The product, HUDC_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.

Official Title
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A Double-blind, Randomized, Placebo-controlled, Parallel Design, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of HUDC_VT in Patients With Bacterial Vaginosis

Conditions
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Bacterial Vaginosis, HUDC_VT, Haudongchun

Intervention / Treatment
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* Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
* Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
* Drug: HUDC_VT (Glucose 400mg)
* Drug: HUDC_VT (Sodium chloride 200mg)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fertile women Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria) light gray adherent vaginal discharge pH >4.5 Presence of clue cells ≥20% Positive 10% KOH whiff test Nugent Score ≥ 4 Exclusion Criteria: Pregnant or breast-feeding patient or planning pregnancy Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization Any condition or circumstance that would interfere with analysis of study results Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HUDC_VT(Glucose 200mg/Sodium chloride 200mg)<br>Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days | Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg)<br>* Vaginal administration, two tablets once a day for 7 days<br>|
| Experimental: HUDC_VT(Glucose 400mg/Sodium chloride 200mg)<br>Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days | Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg)<br>* Vaginal administration, two tablets once a day for 7 days<br>|
| Experimental: HUDC_VT(Glucose 400mg)<br>Glucose 400mg, once a day, two tablets at a time for 7 days | Drug: HUDC_VT (Glucose 400mg)<br>* Vaginal administration, two tablets once a day for 7 days<br>|
| Experimental: HUDC_VT(Sodium chloride 200mg)<br>Sodium chloride 200mg, once a day, two tablets at a time for 7 days | Drug: HUDC_VT (Sodium chloride 200mg)<br>* Vaginal administration, two tablets once a day for 7 days<br>|
| Placebo Comparator: Placebo<br>Placebo, once a day, two tablets at a time for 7 days | Drug: Placebo<br>* Vaginal administration, two tablets once a day for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment |  | at 2 weeks after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic cure rate of bacterial vaginosis at last treatment |  | at 7 days | 
| proportion of patients with Normal Nugent score |  | at 2 weeks after last treatment | 
| proportion of patients with Normal Hay/Ison grade |  | at 2 weeks after last treatment | 
| proportion of patients with Normal Vaginal Fluid pH |  | at 2 weeks after last treatment |