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

NCT03357666 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-12-02

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis
  • HUDC_VT
  • Haudongchun

Interventions

DRUG

HUDC_VT(Glucose 200mg/Sodium chloride 200mg)

Vaginal administration, two tablets once a day for 7 days

DRUG

HUDC_VT (Glucose 400mg/Sodium chloride 200mg)

Vaginal administration, two tablets once a day for 7 days

DRUG

HUDC_VT (Glucose 400mg)

Vaginal administration, two tablets once a day for 7 days

DRUG

HUDC_VT (Sodium chloride 200mg)

Vaginal administration, two tablets once a day for 7 days

DRUG

Placebo

Vaginal administration, two tablets once a day for 7 days

Sponsors & Collaborators

  • Haudongchun Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • WonSeog Choi · Haudongchun Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2018-03-31
Completion
2018-03-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357666 on ClinicalTrials.gov