NCT01293643已完成3 期
A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated
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
- 99
- 主要终点
- Percentage of participants that obtain clinical cure
研究概览
简要总结
This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of vaginal candidiasis
- •No Trichomonas vaginalis or any other protozoa
- •No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections
排除标准
- •Known sensitivity to the formula components
- •Pregnant or nursing patients
- •Any gynecological condition contraindicating the use of vaginal ovule or cream.
- •Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
- •Presence of other sexually transmitted diseases (except from Candidal vaginitis).
- •History of recurrent candidiasis (≥4 episodes per year)
- •Use of intra-uterine device, spermicides, or diaphragms
- •Has metabolic or immune disorder
- •Has abnormal uterine bleeding
研究组 & 干预措施
clindamycin/ketoconazole combination
Experimental
干预措施: 100 mg clindamycin /800 mg ketoconazole vaginal ovule (Drug)
tetracycline hydrochloride/amphotericin B combination
Active Comparator
干预措施: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream (Drug)
结局指标
主要结局
Percentage of participants that obtain clinical cure
时间窗: Baseline up to Day 10
Percentage of participants that obtain microbiological cure
时间窗: Baseline up to Day 10
次要结局
未报告次要终点
研究者
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