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

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

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 Overview

• Status: Unknown
• Conditions: Bacterial Vaginosis; HUDC_VT; Haudongchun
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Guro-gu
    • Seoul, Guro-gu, Korea, Republic of, 08308
      • Recruiting
      • Korea University Guro Hospital
      • Contact: JaeKwan Lee; Phone Number: +82 2-2626-1200; Email: jklee38@korea.ac.kr
      • Principal Investigator: JaeKwan Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Fertile women

2. 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"
3. Nugent Score ≥ 4

Exclusion Criteria:

1. Pregnant or breast-feeding patient or planning pregnancy
2. Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection
3. Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization
4. Any condition or circumstance that would interfere with analysis of study results
5. Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HUDC_VT(Glucose 200mg/Sodium chloride 200mg); Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days	Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg); Vaginal administration, two tablets once a day for 7 days
EXPERIMENTAL: HUDC_VT(Glucose 400mg/Sodium chloride 200mg); Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days	Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg); Vaginal administration, two tablets once a day for 7 days
EXPERIMENTAL: HUDC_VT(Glucose 400mg); Glucose 400mg, once a day, two tablets at a time for 7 days	Drug: HUDC_VT (Glucose 400mg); Vaginal administration, two tablets once a day for 7 days
EXPERIMENTAL: HUDC_VT(Sodium chloride 200mg); Sodium chloride 200mg, once a day, two tablets at a time for 7 days	Drug: HUDC_VT (Sodium chloride 200mg); Vaginal administration, two tablets once a day for 7 days
PLACEBO_COMPARATOR: Placebo; Placebo, once a day, two tablets at a time for 7 days	Drug: Placebo; Vaginal administration, two tablets once a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Haudongchun Co., Ltd.
• Investigators: Study Chair: WonSeog Choi, Haudongchun Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2016
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 30, 2018

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (ACTUAL): November 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: HUDC-VT-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO