Trial | NCT03357666  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    150
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.
Study Started
Mar 22
2016
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Mar 30
2018
Anticipated
Last Update
Dec 02
2017

Drug HUDC_VT(Glucose 200mg/Sodium chloride 200mg) [glucose, sodium chloride]

Vaginal administration, two tablets once a day for 7 days

Drug HUDC_VT (Glucose 400mg/Sodium chloride 200mg) [glucose, sodium chloride]

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

HUDC_VT(Glucose 200mg/Sodium chloride 200mg) Experimental

Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days

HUDC_VT(Glucose 400mg/Sodium chloride 200mg) Experimental

Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days

HUDC_VT(Glucose 400mg) Experimental

Glucose 400mg, once a day, two tablets at a time for 7 days

HUDC_VT(Sodium chloride 200mg) Experimental

Sodium chloride 200mg, once a day, two tablets at a time for 7 days

Placebo Placebo Comparator

Placebo, once a day, two tablets at a time for 7 days

Criteria 

Inclusion Criteria:

Fertile women

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"
Nugent Score ≥ 4

Exclusion Criteria:

Pregnant or breast-feeding patient or planning pregnancy
Patient with candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex virus infection
Patient who received antifungal or antimicrobial therapy (systemic or intravaginal) within 30 days of randomization
Any condition or circumstance that would interfere with analysis of study results
Patient who have a plan to treat other disease (e.g cervical carcinoma) during clinical study period
No Results Posted