NCT02418845已完成3 期
A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
Symbiomix Therapeutics0 个研究点目标入组 189 人开始时间: 2015年5月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 主要终点
- Clinical Outcome Responder Rate
研究概览
简要总结
The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health
- •Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
- •Off-white (milky or gray), thin, homogeneous vaginal discharge
- •Vaginal pH ≥ 4.7
- •Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
- •A positive 10% KOH Whiff test
- •Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)
排除标准
- •Are pregnant, lactating, or planning to become pregnant during the study
- •Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1)
- •Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
- •Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1)
研究组 & 干预措施
SYM-1219
Experimental
Administered orally
干预措施: SYM-1219 (Drug)
Placebo
Placebo Comparator
Administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Outcome Responder Rate
时间窗: Study Days 21-30 (End of Study (EOS))
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
次要结局
- Clinical Outcome Responder Rate (Interim Visit Only)(Study Days 7-14 (interim))
- Gram Stain Slide Nugent Score(Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS))
- Investigator's Clinical Assessment(Study days 21-30 End of Study (EOS))
- Therapeutic Outcome Responder Rate(Study days 7-14 (interim) & study days 21-30 (EOS))
研究者
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