A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mycological Cure 1
研究概览
简要总结
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
详细描述
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.
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
- •Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment
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
- •had used antifungal medication in the week before entry; or
- •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
Terconazole Vaginal Suppository
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
干预措施: Terconazole Vaginal Suppository (Drug)
Fluconazole
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
干预措施: Fluconazole (Drug)
结局指标
主要结局
Mycological Cure 1
时间窗: Between day 7-14 after treatment, an average of 10 days
Based on candida culture
次要结局
- Mycological Cure 2(Between day 28-35 after treatment, an average of 30 days)
研究者
Shangrong Fan
Prof of Obstetrics and Gynecology
Peking University Shenzhen Hospital