CTRI/2014/10/005082已完成3 期
A Phase III, Multicenter, Single dose, Randomized, Single-Blind, Non-Inferiority, Parallel-Group, Comparative, Study to Evaluate Efficacy and Safety of Fenticonazole vaginal capsule compared to Clotrimazole vaginal tablet in the treatment of Subjects with Vaginal Candidiasis.
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 430 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female subjects age 18 to 65 years.
- •2. Diagnosis of symptomatic vaginal candidiasis.
- •3. Presence of vulvovaginal sign as assessed by the investigator at baseline.
排除标准
- •1. Presence of concomitant vaginitis caused by other infections (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhoea).
- •2. Subjects having history of recurrent vaginal candidiasis, defined as occurrence of four or more than four episodes in the previous 12 months.
- •3. Presence of another vaginal condition that would confound the interpretation of clinical response.
- •4. Pregnant or lactating women.
- •5. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the subjectâ??s ability to safely complete the study.
- •6. Hypersensitivity to the imidazoles and their analogues or any component of the formulation.
- •7. History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •8. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
研究者
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