NCT02308033已完成3 期
Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 35
- 主要终点
- Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
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
- •A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
- •Capable of providing written informed consent or assent
- •Currently not menstruating and not anticipating menses during treatment
- •If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
- •Negative pregnancy test
- •Other criteria as identified in the protocol
排除标准
- •Other infectious causes of vulvovaginitis
- •Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
- •Nursing mother
- •Use of any investigational drug within 30 days of enrollment
- •History of hypersensitivity to any ingredient/component of the formulations
- •Other criteria as identified in the protocol
研究组 & 干预措施
Metronidazole vaginal gel
Active Comparator
One applicator full at bedtime
干预措施: Metronidazole (Drug)
Gel vehicle
Placebo Comparator
One applicator full at bedtime
干预措施: Gel vehicle (Drug)
结局指标
主要结局
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
时间窗: 7-14 days after beginning treatment
The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \<20% clue cells
次要结局
- Improvement of BV Clue Cells(7-14 days after beginning treatment)
- Microbiologic Improvement/Cure(7-14 days after beginning treatment)
- Number of Participants With Treatment Emergent Adverse Events(Any time during study participation (up to 30 days))
- Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit(7-14 days after beginning treatment)
研究者
研究点 (35)
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