Clinical trial NCT03357666: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bacterial Vaginosis
HUDC_VT
Haudongchun
Lead sponsor: Haudongchun Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
timeFrame: at 2 weeks after last treatment
Secondary outcomes:
measure: Therapeutic cure rate of bacterial vaginosis at last treatment
timeFrame: at 7 days
measure: proportion of patients with Normal Nugent score
timeFrame: at 2 weeks after last treatment
measure: proportion of patients with Normal Hay/Ison grade
timeFrame: at 2 weeks after last treatment
measure: proportion of patients with Normal Vaginal Fluid pH
timeFrame: at 2 weeks after last treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Haudongchun Co., Ltd.
name: WonSeog Choi
role: STUDY_CHAIR
References: