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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fertile women
- •Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)
- •light gray adherent vaginal discharge
- •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
Arms & Interventions
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
Intervention: HUDC_VT(Glucose 200mg/Sodium chloride 200mg) (Drug)
HUDC_VT(Glucose 400mg/Sodium chloride 200mg)
Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
Intervention: HUDC_VT (Glucose 400mg/Sodium chloride 200mg) (Drug)
HUDC_VT(Glucose 400mg)
Glucose 400mg, once a day, two tablets at a time for 7 days
Intervention: HUDC_VT (Glucose 400mg) (Drug)
HUDC_VT(Sodium chloride 200mg)
Sodium chloride 200mg, once a day, two tablets at a time for 7 days
Intervention: HUDC_VT (Sodium chloride 200mg) (Drug)
Placebo
Placebo, once a day, two tablets at a time for 7 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
Time Frame: at 2 weeks after last treatment
Secondary Outcomes
- 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)