EUCTR2021-001201-75-BE进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal cream in the Treatment of Subjects with Acute Vulvovaginal Candidiasis
Female Healthcare Purna0 个研究点目标入组 95 人开始时间: 2021年7月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
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
- 性别
- Female
入选标准
- •Subjects must be generally healthy, non-pregnant females 18-50 years of age at Screening Visit.
- •Subjects must have an acute VVC episode at Screening Visit, 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.
- •Subjects of childbearing potential must have a negative pregnancy test before randomization and may not be lactating or planning to become pregnant during the study period.
- •Subjects of childbearing potential must agree to use highly effective methods of contraception or to abstain from sexual intercourse.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with the presence of concomitant vulvovaginitis caused by other pathogens (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, or Neisseria gonorrhoeae) at Screening Visit, or any other infection that requires antibiotic treatment.
研究者
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