The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 133
- 试验地点
- 5
- 主要终点
- Percentage of Participants With Relapse 2 Months Post-treatment
研究概览
简要总结
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects in reproductive age and older than 18 year
- •Subjects with normal sexual activity
- •Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge
- •Subjects with Nugent Score greater than or equal to 7
- •Subjects who are willing to use contraception
- •Subjects who are willing to refrain from the use of other vaginal products throughout the study
- •Subjects who sign informed consent form and agree to follow-up on time
排除标准
- •Subjects without sexual activity
- •Pregnant or lactating female subjects
- •Subjects with a history of recurrent bacterial vaginosis
- •Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection.
- •Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy
- •Subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant, cyclosporine or disulfiram by the time of inclusion (interactions with other products and metronidazole)
- •Subjects who are undergoing systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion
- •Female subjects with a history of peripheral neuropathy
- •Female subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
- •Subjects who are unable to give written informed consent
研究组 & 干预措施
Colposeptine (A)
干预措施: Colposeptine (Drug)
Metronidazole (B)
干预措施: Metronidazole (Drug)
结局指标
主要结局
Percentage of Participants With Relapse 2 Months Post-treatment
时间窗: 2 months post-treatment
Relapse: recurrence of the symptoms of bacterial vaginosis \[BV\] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.
次要结局
- Percentage of Participants With Relapse 1 Month Post-treatment(1 month post-treatment)
- Change From Baseline in Nugent Score at 2 Months Post-treatment(Baseline and Month 2 post-treatment)
- Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment(Baseline and Month 2 post-treatment)
- Number of Participants With Adverse Events (AEs)(Up to 2 months post-treatment)
- Percentage of Participants Cured(1 week post-treatment)