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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002268

Enrollment

150

Registered

2017-03-16

Start date

2016-03-22

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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% Potassium Hydroxide 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

Design outcomes

Primary

Measure	Time frame
Therapeutic cure rate of bacterial vaginosis at at 2 weeks after last treatment	—

Secondary

Measure	Time frame
Therapeutic cure rate of bacterial vaginosis at last treatment ;proportion of patients with Normal Nugent score ;proportion of patients with Normal Hay/Ison grade ;proportion of patients with Normal Vaginal Fluid pH	—

Countries

Korea, Republic of

Contacts

Public ContactJae-kwan Lee

Koera University Guro Hospital

jklee38@gmail.com+82-2-2626-1200

Outcome results