KCT0002268招募中未知
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
Koera University Guro Hospital0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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