A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 16
- 主要终点
- Cure of Bacterial Vaginosis
研究概览
简要总结
The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.
详细描述
:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are females at least 18 years of age in good general health who are not menopausal.
- •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 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 Low Dose
Administered orally
干预措施: SYM-1219 (Drug)
SYM-1219 High Dose
Administered orally
干预措施: SYM-1219 (Drug)
Placebo
Administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Cure of Bacterial Vaginosis
时间窗: Study Days 21-30
Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
次要结局
- Cure of Bacterial Vaginosis(Study Days 21-30)
- Number of Patients With Therapeutic Cure(Study Days 21-30)
- Number of Patients With a Normal Nugent Score(Study Days 21-30)