Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 51
- 主要终点
- Clinical Cure of Mixed Infection (BV and VVC) 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 terconazole/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
Terconazole vaginal gel
One applicator full at bedtime
干预措施: Terconazole (Drug)
Metronidazole vaginal gel
One applicator full at bedtime
干预措施: Metronidazole (Drug)
Terconazole/metronidazole vaginal gel
One applicator full at bedtime
干预措施: Terconazole/metronidazole (Drug)
结局指标
主要结局
Clinical Cure of Mixed Infection (BV and VVC) 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 of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is \<20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis
次要结局
- Cure of the VVC Component of Mixed Infection(7-14 days after beginning treatment)
- Microbiologic and Mycologic Cure(7-14 days after beginning treatment)
- Cure of the BV Component of Mixed Infection(7-14 days after beginning treatment)
- Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit(7-14 days after beginning treatment)
- Number of Participants With Treatment Emergent Adverse Events(Any time during study participation (up to 30 days))