ACTRN12609000880246尚未招募不适用
Phase 3b, comparative and randomized study to evaluate the efficacy and safety of ketoconazole associated to clindamycin in vaginal ovules versus tetracyclin associated to amphotericin B in vaginal cream in bacterial vaginosis and mixed or isolated vaginal candidiasis treatment.
Schering-Plough Industria Farmaceutica Ltda.0 个研究点目标入组 100 人开始时间: 2009年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •Patients between 18 and 45 years old;
- •- Diagnosis of vaginal candidiasis with laboratorial confirmation, and/or diagnosis of bacterial vaginosis according to Amsel and Nugent criteria;
- •- Absence of Trichomonas vaginallis or other protozoal.
- •- Absence of clinical evidence of infection with Neisseria gonorrhoeae, Chlamydia trachomatis or viral infection.
排除标准
- •- Patients with known sensibility to formula compounds;
- •- Pregnant patients or in lactancy period;
- •- Any ginecologic condition that contra-indicate the use of vaginal ovules or creams;
- •- Use of any other local or sistemic anti-bacterial, anti-protozoary or anti-fungic agent in the two weeks before the study or during the same time;
- •- Pacients with other sexually transmissive diseases (except candida vaginitis);
- •- Patients with history of candidiasis (4 or more episodes per year);
- •- Use of intrauterine device, spermicides or diaphragm;
- •- Patients with metabolic or uncontrolled immune disorders;
- •- Patients with anormal uterine bleeding.
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