NCT05788991终止4 期
Comparative Study of the Efficacy and Safety of Vaginally Applied Dequalinium Chloride (10 mg) and Orally Applied Metronidazole (2 x 500 mg) in the Treatment of Bacterial Vaginosis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Medinova AG
- 入组人数
- 151
- 试验地点
- 14
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
The goal of this clinical trial is to show the efficacy and safety of dequalinium chloride in the treatment of bacterial vaginosis compared to metronidazole.
详细描述
Eligible patients who signed informed consent were randomized to receive treatment with either dequalinium chloride (+ oral placebo) or metronidazole (+ vaginal placebo) for up to 7 days. Primary objective was clinical cure rate at one week after start of treatment. Control visits to assess outcomes were done after end of treatment and after one month.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal woman ≥18 years
- •Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1) greyish white thin discharge, 2) postassium hydroxide (KOH) test or 'fishy' smell, 3) microscopic presence of > 20% clue cells, 4) vaginal pH > 4.5)
- •Signed Written Informed Consent to participate in this study
排除标准
- •Pregnancy and/or lactation based on urine Pregnancy test (women with childbearing potential should use any contraception excluding vaginal methods like vaginal ring, etc.)
- •Uterine bleeding (including menstruation) or vaginal bleeding of unknown origin
- •Ulcerations/erosions of vaginal mucosa or cervix uteri
- •Patients with clinical symptoms and findings of Candida vulvovaginitis and/or Aerobic vaginitis
- •Clinically manifest or suspicion of sexually transmitted infections (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis
- •Use of any antimicrobial treatment (local or systemic) 14 days before entry the study
- •Use of any vaginal medication or vaginal douching 7 days before entry the study
- •Unwillingness to refrain from alcohol consumption during treatment, and 48 hours after treatment
- •Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetes mellitus, severe psychiatric conditions, etc.), including diseases treated with immunosuppressive therapies, systemic corticosteroids, or warfarin
- •Known or suspected hypersensitivity to one of the study medications, inclusive of their excipients
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (including inability to fill-in electronic patient diary)
- •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
Dequalinium chloride
Experimental
Dequalinium chloride 10 mg vaginal tablets
干预措施: Dequalinium Chloride (Drug)
Metronidazole
Active Comparator
Metronidazole 500 mg oral tablets
干预措施: Metronidazole Oral (Drug)
结局指标
主要结局
Clinical Cure Rate
时间窗: One week after randomization (C1)
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
次要结局
- Clinical Cure Rate(One month after randomization (C2))
- Bacteriological Cure Rate(One week & one month)
- Therapeutic Cure(One week & one month)
- Subjective Assessment of Efficacy(One week)
- Subjective Assessment of Tolerability(One week)
研究者
研究点 (14)
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