Efficacy and Safety of Vaginal Suppositories Containing Combination of Natamycin and Lactulose in Treatment of Vulvovaginal Candidiasis: International, Randomized, Controlled, Superiority Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2
研究概览
简要总结
The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg vaginal suppositories. The second objective of the study was to investigate the safety of the combination suppositories in the treatment of vulvovaginal candidiasis in non-pregnant adult females.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •two or more of the following signs and symptoms of vulvovaginal candidiasis: white or yellowish-white curd-like, thick or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination (dysuria);
- •yeast cells in the vaginal swab specimen;
- •vaginal pH ≤ 4.5.
排除标准
- •a clinical and laboratory diagnosis of bacterial vaginosis; vulvovaginitis caused by specific pathogens such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae; chronic inflammatory, atrophic, or oncologic diseases of the female genital tract; previous surgery on external or internal genitalia within 6 months; childbirth and abortion within 6 months.
研究组 & 干预措施
Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories
干预措施: Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories (Combination Product)
Lactulose 300 mg vaginal suppositories
干预措施: Lactulose 300 mg vaginal suppositories (Drug)
Pimafucin® (natamycin) 100 mg vaginal suppositories
干预措施: Pimafucin® (natamycin) 100 mg vaginal suppositories (Drug)
结局指标
主要结局
Proportion (%) of patients who achieved a clinical response (recovery) at Visit 2
时间窗: 7 days
The clinical response was considered as the absence of significant signs and symptoms of VVC (white or yellowish-white curd-like, thick, or creamy vaginal discharge; vulvar itching, burning and pain; anogenital itching and burning; discomfort in the vulva; itching, burning, painful urination \[dysuria\])
次要结局
- Proportion of patients with overall (clinical and microscopic) recovery at Visits 2 and 3(24 days)
- Proportion (%) of patients with the clinical response at Visit 3(24 days)
- Microscopic change in lactobacilli count in vaginal specimens at Visits 2 and 3 compared to baseline (Visit 0)(24 days)
- Proportion (%) of patients with microscopic recovery (absence of Candida spp. at Visits 2 and 3(24 days)
- Patient's efficacy assessment by the 5-point scale at Visits 2, 3(24 days)
- Incidence of adverse events(24 days)