Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Medinova AG
- 入组人数
- 321
- 试验地点
- 14
- 主要终点
- clinical cure rate
研究概览
简要总结
The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.
详细描述
An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bacterial vaginosis
- •Women aged 18-55 years
排除标准
- •Pregnancy or lactation
- •Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
- •Acute infections of the upper genital tract
- •Clinical Symptoms of a vulvovaginal Candidiasis
- •Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
研究组 & 干预措施
Dequalinium chloride 10mg
干预措施: Dequalinium chloride (Drug)
clindamycin vaginal cream 2%
干预措施: Clindamycin (Drug)
结局指标
主要结局
clinical cure rate
时间窗: 1 week (on average)
Clinical cure rate based on Amsel criteria. For cure, clue cells have to be negative and not more than one of the other criteria positive
Clinical cure rate
时间窗: 4 weeks (on average)
Clinical cure rate based on Amsel criteria, where cure was defined as clue cells being negative and not more than one of the other criteria positive
次要结局
- Treatment failure(4 weeks)
- Incidence of ADRs(4 weeks)