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

Phase 2

• Conditions: Bacterial Vaginosis; HUDC_VT; Haudongchun
• Interventions: Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg); Drug: HUDC_VT (Glucose 400mg); Drug: Placebo; Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg); Drug: HUDC_VT (Sodium chloride 200mg)

• Registration Number: NCT03357666
• Lead Sponsor: Haudongchun Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-22
• Status Verified: 2017-11
• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-12-02
• Primary Completion: 2018-03
• Study Completion: 2018-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HUDC_VT(Glucose 400mg/Sodium chloride 200mg)	HUDC_VT (Glucose 400mg/Sodium chloride 200mg)	Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
HUDC_VT(Glucose 400mg)	HUDC_VT (Glucose 400mg)	Glucose 400mg, once a day, two tablets at a time for 7 days
Placebo	Placebo	Placebo, once a day, two tablets at a time for 7 days
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)	HUDC_VT(Glucose 200mg/Sodium chloride 200mg)	Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days
HUDC_VT(Sodium chloride 200mg)	HUDC_VT (Sodium chloride 200mg)	Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Guro-gu, Korea, Republic of