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Status unknownNCT03357666Updated Dec 2, 2017

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

A Phase 2 interventional study of HUDC_VT(Glucose 200mg/Sodium chloride 200mg) and HUDC_VT (Glucose 400mg/Sodium chloride 200mg) in Bacterial Vaginosis, HUDC_VT and Haudongchun, sponsored by Haudongchun Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Haudongchun Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Mar 2016, registered Nov 2017).

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Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Bacterial Vaginosis
  • HUDC_VT
  • Haudongchun

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03

In context

Vaginosis, Bacterial

240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

This is the only study on the registry with Haudongchun Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • 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)

  • 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)

  • Experimental
    HUDC_VT(Glucose 400mg)

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

    Drug: HUDC_VT (Glucose 400mg)

  • 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)

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugHUDC_VT(Glucose 200mg/Sodium chloride 200mg)

    Drug page: Glucose

    Vaginal administration, two tablets once a day for 7 days

  • DrugHUDC_VT (Glucose 400mg/Sodium chloride 200mg)

    Drug page: Glucose

    Vaginal administration, two tablets once a day for 7 days

  • DrugHUDC_VT (Glucose 400mg)

    Vaginal administration, two tablets once a day for 7 days

  • DrugHUDC_VT (Sodium chloride 200mg)

    Vaginal administration, two tablets once a day for 7 days

  • DrugPlacebo

    Vaginal administration, two tablets once a day for 7 days

06

What researchers measure

Primary outcomes

  1. Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment

    Time frame: at 2 weeks after last treatment

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Korea University Guro Hospital
    Seoul, Guro-gu 08308, Korea, Republic of
    Recruiting
    • JaeKwan Lee · Contactjklee38@korea.ac.kr · +82 2-2626-1200
    • JaeKwan Lee · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2016 (actual). Primary completion is estimated for Mar 2018, 24 months after the start.

Of 14 phase 2 interventional studies under Vaginosis, Bacterial, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 41. This study's planned 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2017
First posted
Nov 30, 2017
StartActual
Mar 22, 2016
Primary completionEst.
Mar 2018
CompletionEst.
Mar 30, 2018
Last update
Dec 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03357666
Lead sponsor
Haudongchun Co., Ltd.
Responsible party
Sponsor
First posted
Nov 30, 2017
Start date
Mar 22, 2016
Primary completion
Mar 2018 (estimated)
Completion
Mar 30, 2018 (estimated)
Last update
Dec 2, 2017

Study contacts

MiYeon Choi
Contact
cbg@hudc.co.kr
+82 70-7729-5704
WonSeog Choi
study chair · Haudongchun Co., Ltd.
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Glucose · Sodium Chloride

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