EUCTR2018-001270-26-HU进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects with Recurrent Vulvovaginal Candidiasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Subjects must be generally healthy, non-pregnant females 12 years of age and older as of Screening. In Hungary and Czech Republic only, subjects must be generally healthy, non-pregnant females 18 years of age and older as of Screening.
- •2) Subjects must have a history of recurrent VVC as defined by three (3) or more episodes of acute VVC in the past 12 months, including the episode confirmed at Screening, with at least one episode (not including the current episode) documented by a positive culture, PCR, Affirm test, KOH test, Gram stain or a documented Pap test in the prior 12 months revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
- •3) Subjects must have an acute VVC episode at Screening, defined as a total signs and symptoms score of =3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells.
- •4) Subjects must have a composite vulvovaginal signs and symptoms score of <3 at the Baseline (Day 1) Visit.
- •5) Subjects must have a documented Pap test at Screening or within the current standard of care guidelines for the appropriate age requirement, reported as either negative for intraepithelial lesion or malignancy” or ASCUS-atypical squamous cells of undetermined significance” (not applicable to subjects with a history of total hysterectomy).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 290
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Subjects must not have the presence of concomitant vulvovaginitis caused by other pathogens (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, or Neisseria gonorrhoeae) at Screening visit and at the Day 1 visit if an infection is suspected.
- •2) Subjects must not have an active HPV infection as evidenced by visible condylomas on vulvovaginal examination at Screening and Day 1 visits.
- •3) Subjects must not have the presence or a history of another vaginal or vulvar condition(s) that in the Investigator’s opinion would confound the interpretation of clinical response.
- •4) Subjects must not have a history of cervical cancer.
研究者
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