Bacterial VaginosisPhase 2NCT03357666
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis
A Phase 2 study testing HUDC_VT(Glucose 200mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg/Sodium chloride 200mg) and HUDC_VT (Glucose 400mg) in people with Bacterial Vaginosis and HUDC_VT, run by Haudongchun Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis, HUDC_VT, Haudongchun
- What is being tested?
- HUDC_VT(Glucose 200mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg/Sodium chloride 200mg) and HUDC_VT (Glucose 400mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2016to 30 Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, Guro-gu, 08308
JaeKwan Lee, +82 2-2626-1200, jklee38@korea.ac.kr
JaeKwan Lee
About this study
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
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.
Read more
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.
- Conditions
- Bacterial Vaginosis, HUDC_VT, Haudongchun
- Being tested
- HUDC_VT(Glucose 200mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg), HUDC_VT (Sodium chloride 200mg), Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)Drug
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Glucose 400mg/Sodium chloride 200mg)Drug
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Glucose 400mg)Drug
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Sodium chloride 200mg)Drug
Vaginal administration, two tablets once a day for 7 days
PlaceboDrug
Vaginal administration, two tablets once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| HUDC_VT(Glucose 200mg/Sodium chloride 200mg) | Experimental | Glucose 200mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days Receives: Drug: HUDC_VT(Glucose 200mg/Sodium chloride 200mg) |
| HUDC_VT(Glucose 400mg/Sodium chloride 200mg) | Experimental | Glucose 400mg/Sodium chloride 200mg, once a day, two tablets at a time for 7 days Receives: Drug: HUDC_VT (Glucose 400mg/Sodium chloride 200mg) |
| HUDC_VT(Glucose 400mg) | Experimental | Glucose 400mg, once a day, two tablets at a time for 7 days Receives: Drug: HUDC_VT (Glucose 400mg) |
| HUDC_VT(Sodium chloride 200mg) | Experimental | Sodium chloride 200mg, once a day, two tablets at a time for 7 days Receives: Drug: HUDC_VT (Sodium chloride 200mg) |
| Placebo | Placebo comparator | Placebo, once a day, two tablets at a time for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
Measured: at 2 weeks after last treatment
Secondary outcomes (4)
Therapeutic cure rate of bacterial vaginosis at last treatment
Measured: at 7 days
proportion of patients with Normal Nugent score
Measured: at 2 weeks after last treatment
proportion of patients with Normal Hay/Ison grade
Measured: at 2 weeks after last treatment
proportion of patients with Normal Vaginal Fluid pH
Measured: at 2 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start22 Mar 2016
- Primary completionMar 2018 (estimated)
- Study completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haudongchun Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WonSeog Choi, Study chair, Haudongchun Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357666
- Sponsor's protocol ID
- HUDC-VT-201
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03357666
- Acronym / sponsor ID
- HUDC-VT-201
- Conditions
- Bacterial Vaginosis, HUDC_VT, Haudongchun
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Haudongchun Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HUDC_VT(Glucose 200mg/Sodium chloride 200mg) | Experimental | Drug: 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(Glucose 400mg/Sodium chloride 200mg) | Experimental | Drug: 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) | Experimental | Drug: HUDC_VT (Glucose 400mg)Glucose 400mg, once a day, two tablets at a time for 7 days |
| HUDC_VT(Sodium chloride 200mg) | Experimental | Drug: HUDC_VT (Sodium chloride 200mg)Sodium chloride 200mg, once a day, two tablets at a time for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, once a day, two tablets at a time for 7 days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Fertile women
- Clinical diagnosis of bacterial vaginosis with criteria on below (3 out of 4 fulfilled criteria)
- Nugent Score ≥ 4
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUDC_VT(Glucose 200mg/Sodium chloride 200mg)Vaginal administration, two tablets once a day for 7 days | Drug | HUDC_VT(Glucose 200mg/Sodium chloride 200mg) |
| HUDC_VT (Glucose 400mg/Sodium chloride 200mg)Vaginal administration, two tablets once a day for 7 days | Drug | HUDC_VT(Glucose 400mg/Sodium chloride 200mg) |
| HUDC_VT (Glucose 400mg)Vaginal administration, two tablets once a day for 7 days | Drug | HUDC_VT(Glucose 400mg) |
| HUDC_VT (Sodium chloride 200mg)Vaginal administration, two tablets once a day for 7 days | Drug | HUDC_VT(Sodium chloride 200mg) |
| PlaceboVaginal administration, two tablets once a day for 7 days | Drug | Placebo |
Primary outcome
Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment
Time frame: at 2 weeks after last treatment
4 secondary outcomes
Therapeutic cure rate of bacterial vaginosis at last treatment
Time frame: at 7 days
proportion of patients with Normal Nugent score
Time frame: at 2 weeks after last treatment
proportion of patients with Normal Hay/Ison grade
Time frame: at 2 weeks after last treatment
proportion of patients with Normal Vaginal Fluid pH
Time frame: at 2 weeks after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WonSeog Choi study chair
Haudongchun Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HUDC_VT(Glucose 200mg/Sodium chloride 200mg), HUDC_VT (Glucose 400mg/Sodium chloride 200mg) and HUDC_VT (Glucose 400mg) in people with Bacterial Vaginosis and HUDC_VT, run by Haudongchun Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MiYeon Choi (+82 70-7729-5704, cbg@hudc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment (time frame: at 2 weeks after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.