EUCTR2018-001269-18-GB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
- 性别
- Female
入选标准
- •1) Subjects must be generally healthy, post-menarchal, non-pregnant
- •females 12 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, or other approved diagnostic tests.
- •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
- •timeline per current standard of care guidelines for the appropriate age
- •requirement. Results must be 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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