search
Back to results

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

Primary Purpose

Bacterial Vaginosis, HUDC_VT, Haudongchun

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
HUDC_VT (Glucose 400mg)
HUDC_VT (Sodium chloride 200mg)
Placebo
Sponsored by
Haudongchun Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Guro HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

HUDC_VT(Glucose 200mg/Sodium chloride 200mg)

HUDC_VT(Glucose 400mg/Sodium chloride 200mg)

HUDC_VT(Glucose 400mg)

HUDC_VT(Sodium chloride 200mg)

Placebo

Arm Description

Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Glucose 400mg, once a day, two tablets at a time for 7 days

Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Placebo, once a day, two tablets at a time for 7 days

Outcomes

Primary Outcome Measures

Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment

Secondary Outcome Measures

Therapeutic cure rate of bacterial vaginosis at last treatment
proportion of patients with Normal Nugent score
proportion of patients with Normal Hay/Ison grade
proportion of patients with Normal Vaginal Fluid pH

Full Information

First Posted
November 23, 2017
Last Updated
November 29, 2017
Sponsor
Haudongchun Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03357666
Brief Title
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haudongchun Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis, HUDC_VT, Haudongchun

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Arm Type
Experimental
Arm Description
Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
Arm Title
HUDC_VT(Glucose 400mg/Sodium chloride 200mg)
Arm Type
Experimental
Arm Description
Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
Arm Title
HUDC_VT(Glucose 400mg)
Arm Type
Experimental
Arm Description
Glucose 400mg, once a day, two tablets at a time for 7 days
Arm Title
HUDC_VT(Sodium chloride 200mg)
Arm Type
Experimental
Arm Description
Sodium chloride 200mg, once a day, two tablets at a time for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, once a day, two tablets at a time for 7 days
Intervention Type
Drug
Intervention Name(s)
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Intervention Description
Vaginal administration, two tablets once a day for 7 days
Intervention Type
Drug
Intervention Name(s)
HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
Intervention Description
Vaginal administration, two tablets once a day for 7 days
Intervention Type
Drug
Intervention Name(s)
HUDC_VT (Glucose 400mg)
Intervention Description
Vaginal administration, two tablets once a day for 7 days
Intervention Type
Drug
Intervention Name(s)
HUDC_VT (Sodium chloride 200mg)
Intervention Description
Vaginal administration, two tablets once a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vaginal administration, two tablets once a day for 7 days
Primary Outcome Measure Information:
Title
Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
Time Frame
at 2 weeks after last treatment
Secondary Outcome Measure Information:
Title
Therapeutic cure rate of bacterial vaginosis at last treatment
Time Frame
at 7 days
Title
proportion of patients with Normal Nugent score
Time Frame
at 2 weeks after last treatment
Title
proportion of patients with Normal Hay/Ison grade
Time Frame
at 2 weeks after last treatment
Title
proportion of patients with Normal Vaginal Fluid pH
Time Frame
at 2 weeks after last treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MiYeon Choi
Phone
+82 70-7729-5704
Email
cbg@hudc.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WonSeog Choi
Organizational Affiliation
Haudongchun Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Guro-gu
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JaeKwan Lee
Phone
+82 2-2626-1200
Email
jklee38@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
JaeKwan Lee

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs