NCT02242695已完成4 期
Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Medinova AG
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical cure rate
研究概览
简要总结
A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score, Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3).
- •Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts.
- •normal vaginal pH (higher than 4.5) at baseline.
- •Women aged 18 - 45 years old.
- •Women can comply with all clinical trial instructions, and can return to all follow-up visits.
- •Signed Written Informed Consent to participate in this study.
排除标准
- •Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).
- •Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections
- •Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study.
- •Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study.
- •Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
- •Cervicitis, abnormal PAP smear in the last 6 month.
- •Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
- •Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.
- •Women having menstruation bleeding at enrolment.
- •Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
- •Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study.
- •Patient is relative of, or staff directly reporting to, the investigator.
研究组 & 干预措施
Fluomizin vaginal tablets
Experimental
Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
干预措施: Fluomizin vaginal tablets (Drug)
Canesten vaginal tablets
Active Comparator
Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
干预措施: Canesten vaginal tablets (Drug)
结局指标
主要结局
Clinical cure rate
时间窗: Control 1 at day 4 after therapy end
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2
次要结局
- Microbiological cure rate(Control 2 at 6 weeks after therapy end)
- Therapeutic cure rate(Control 2 at 6 weeks after therapy end)
- Individual clinical signs and symptoms(Control 2 at 6 weeks after therapy end)
- Presence of dyspareunia(Control 2 at 6 weeks after therapy end)
- Direct microscopy (wet smear)(Control 2 at 6 weeks after therapy end)
- vaginal pH(Control 2 at 6 weeks after therapy end)
- Candida culture(Control 2 at 6 weeks after therapy end)
- Global assessment of efficacy(Control 2 at 6 weeks after therapy end)
- Global assessment of tolerability(Control 2 at 6 weeks after therapy end)
- Clinical cure rate(Control 2 at 6 weeks after therapy end)
- Presence of external dysuria(Control 2 at 6 weeks after therapy end)
- Patient Satisfaction(Control 2 at 6 weeks after therapy end)
- Adverse event(Control 2 at 6 weeks after therapy end)
研究者
研究点 (1)
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