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临床试验/ACTRN12614001258640
ACTRN12614001258640终止4 期

A randomized, double-blinded study investigating the safety and efficacy of daily low-dose oral fluconazole versus weekly fluconazole in patients with chronic vulvovaginal candidiasis

Royal North Shore Hospital0 个研究点目标入组 200 人开始时间: 2014年12月2日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
200

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
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
Female

入选标准

  • 18 years and older
  • Premenopausal
  • Chronic vulvovaginal candidiasis as per diagnostic criteria*
  • Willingness to give written informed consent and willingness to participate and comply with the study
  • The diagnostic criteria established are:
  • Diagnostic: One major + 5 minor criteria
  • Presumptive: One major + 3-4 minor criteria
  • Major Criterion:
  • - Chronic non-erosive, nonspecific vulvovaginitis
  • Minor Criteria:
  • - Positive vaginal swab either on presentation or in the past
  • - Soreness
  • - Cyclicity
  • - Dyspareunia
  • - Previous response to antifungal therapy (even if incomplete)
  • - Exacerbation with antibiotics
  • - Swelling
  • - Discharge

排除标准

  • Patients who are pregnant, lactating, or who are planning to become pregnant
  • Patients with a history of hypersensitivity to fluconazole
  • Patients with severe renal dysfunction
  • Patients with liver disease
  • Patients who are clinically menopausal

研究者

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