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

• ClinicalTrials.gov Identifier: NCT03357666
• Recruitment Status: Unknown
• First Posted: November 30, 2017
• Last Update Posted: December 2, 2017
• Sponsor: Haudongchun Co., Ltd.
• Information provided by (Responsible Party): Haudongchun Co., Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Bacterial Vaginosis; HUDC_VT; Haudongchun	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	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 22, 2016
• Estimated Primary Completion Date: March 2018
• Estimated Study Completion Date: March 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment [ Time Frame: at 2 weeks after last treatment ]

Secondary Outcome Measures :

1. Therapeutic cure rate of bacterial vaginosis at last treatment [ Time Frame: at 7 days ]
2. proportion of patients with Normal Nugent score [ Time Frame: at 2 weeks after last treatment ]
3. proportion of patients with Normal Hay/Ison grade [ Time Frame: at 2 weeks after last treatment ]
4. proportion of patients with Normal Vaginal Fluid pH [ Time Frame: at 2 weeks after last treatment ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: MiYeon Choi; +82 70-7729-5704; cbg@hudc.co.kr

Locations

Korea, Republic of

Korea University Guro Hospital; Recruiting

Seoul, Guro-gu, Korea, Republic of, 08308

Contact: JaeKwan Lee +82 2-2626-1200 jklee38@korea.ac.kr

Principal Investigator: JaeKwan Lee

Sponsors and Collaborators

Haudongchun Co., Ltd.

Investigators

• Study Chair: WonSeog Choi; Haudongchun Co., Ltd.

More Information

• Responsible Party: Haudongchun Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03357666
• Other Study ID Numbers: HUDC-VT-201
• First Posted: November 30, 2017
• Last Update Posted: December 2, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Vaginosis, Bacterial; Vaginal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis