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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03357666
Other study ID # HUDC-VT-201
Secondary ID
Status Recruiting
Phase Phase 2
First received November 23, 2017
Last updated November 29, 2017
Start date March 22, 2016
Est. completion date March 30, 2018

Study information

Verified date November 2017
Source Haudongchun Co., Ltd.
Contact MiYeon Choi
Phone +82 70-7729-5704
Email cbg@hudc.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 30, 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 50 Years
Eligibility 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


Intervention

Drug:
HUDC_VT(Glucose 200mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Glucose 400mg/Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Glucose 400mg)
Vaginal administration, two tablets once a day for 7 days
HUDC_VT (Sodium chloride 200mg)
Vaginal administration, two tablets once a day for 7 days
Placebo
Vaginal administration, two tablets once a day for 7 days

Locations

Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul Guro-gu

Sponsors (1)

Lead Sponsor Collaborator
Haudongchun Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic cure rate of bacterial vaginosis at 2 weeks after last treatment at 2 weeks after last treatment
Secondary Therapeutic cure rate of bacterial vaginosis at last treatment at 7 days
Secondary proportion of patients with Normal Nugent score at 2 weeks after last treatment
Secondary proportion of patients with Normal Hay/Ison grade at 2 weeks after last treatment
Secondary proportion of patients with Normal Vaginal Fluid pH at 2 weeks after last treatment
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