Status:
UNKNOWN
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis
Lead Sponsor:
Haudongchun Co., Ltd.
Conditions:
Bacterial Vaginosis
HUDC_VT
Eligibility:
FEMALE
19-50 years
Phase:
PHASE2
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. Vagi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03357666
Start Date
March 22 2016
End Date
March 30 2018
Last Update
December 2 2017
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, Guro-gu, South Korea, 08308