A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 157
- 试验地点
- 10
- 主要终点
- Therapeutic Outcome: Response Rate
研究概览
简要总结
As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical symptoms and signs of vulvovaginal candidiasis.
- •Patients tested positive for Candida by fungal culture.
- •Patients who can agree not to have intercourse up to 28 days after dosing.
排除标准
- •Patients with a history of hypersensitivity to fluconazole.
- •Patients with severe renal dysfunction.
- •Patients with liver disorder.
研究组 & 干预措施
Fluconazole
干预措施: Fluconazole (Drug)
结局指标
主要结局
Therapeutic Outcome: Response Rate
时间窗: Day 7, Day 14 and Day 28
Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication. Primary evaluation of therapeutic outcome was on Day 28. Response rate was calculated based on the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
次要结局
- Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Mycological Efficacy: Eradication Rate(Day 7, Day 14 and Day 28)
- Total Scores for Clinical Symptoms(Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28)
- Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Clinical Efficacy: Cure and Improvement Rate(Day 7, Day 14 and Day 28)
- Clinical Efficacy: Cure Rate(Day 7, Day 14 and Day 28)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Before dosing and 2, 24, 48 and 168 hours after dosing)
- Maximum Observed Plasma Concentration (Cmax)(Before dosing and 2, 24, 48 and 168 hours after dosing)