An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Therapeutic Efficacy 2
研究概览
简要总结
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
详细描述
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
- •Subject completes the informed consent process
- •Subject agrees to take study medication when scheduled
- •Subject complies with all clinical trial instructions. Commits to all follow-up visits
排除标准
- •had any other sexually transmitted disease or gynaecological abnormality requiring treatment
- •had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
- •were pregnant
- •had used antifungal medication in the week before entry
- •were expected to menstruate within seven days of the start of treatment
- •infected more than one candida species
研究组 & 干预措施
Clotrimazole vaginal tablet
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
干预措施: Clotrimazole vaginal tablet (Drug)
Fluconazole
2 doses of 150 mg oral Fluconazole (at day1 and day4)
干预措施: Fluconazole (Drug)
结局指标
主要结局
Therapeutic Efficacy 2
时间窗: at days 30-35 follow-up
The clinical cure rates of clotrimazole and fluconazol
Therapeutic Efficacy 3
时间窗: at days 7-14 follow-up
Mycological cure of clotrimazole group and fluconazole group
Therapeutic Efficacy 4
时间窗: at days30-35 follow-up
Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.
Therapeutic Efficacy 1
时间窗: 7-14 days after treatment (=visit 2)
The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.
次要结局
- Adverse Events 1(at day 7-14 follow up)
- Adverse Events 3(at day 7-14 follow up)
- Total Adverse Events(at day 7-14 follow up)
- Adverse Events 2(at day 7-14 follow up)
- Adverse Events 4(at day 7-14 follow up)
研究者
Shangrong Fan
Prof of Dept of Obstetrics and Gynecology
Peking University Shenzhen Hospital