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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03357666
• Other study ID #: HUDC-VT-201
• Status: Recruiting
• Phase: Phase 2
• First received: November 23, 2017
• Last updated: November 29, 2017
• Start date: March 22, 2016
• Est. completion date: March 30, 2018

Study information

• Verified date: November 2017
• Source: Haudongchun Co., Ltd.
• Contact: MiYeon Choi
• Phone: +82 70-7729-5704
• Email: cbg[@]hudc.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 30, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Haudongchun
• HUDC_VT
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
• HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
• HUDC_VT (Glucose 400mg)
Vaginal administration, two tablets once a day for 7 days
• HUDC_VT (Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
• Placebo
Vaginal administration, two tablets once a day for 7 days

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro-gu

Sponsors (1)

Lead Sponsor	Collaborator
Haudongchun Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment		at 2 weeks after last treatment
Secondary	Therapeutic cure rate of bacterial vaginosis at last treatment		at 7 days
Secondary	proportion of patients with Normal Nugent score		at 2 weeks after last treatment
Secondary	proportion of patients with Normal Hay/Ison grade		at 2 weeks after last treatment
Secondary	proportion of patients with Normal Vaginal Fluid pH		at 2 weeks after last treatment