NCT07418918已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Lactobacillus Bicomponent Viable Capsules for Vaginal Use in the Treatment of Bacterial Vaginosis
Guangdong Longchuangji Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年1月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.
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
- Double (Participant, Investigator)
盲法说明
This trial employs a double-blind method, meaning that neither the investigator nor the subject knows which treatment the subject is receiving. Both the Vaginal Lactobacillus Dual Probiotic Capsules used in the treatment group and the placebo used in the placebo group are provided by Guangdong Longchuangji Pharmaceutical Co., Ltd. The investigational drug and the control drug are nearly identical in appearance, shape, specification, and dosage.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participates in the study, and provides written informed consent prior to trial commencement;
- •Female aged 18 to 50 years (inclusive of the boundary values);
- •History of sexual activity, willing to undergo vaginal administration of medication, and agrees to refrain from using other intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and from engaging in sexual activity throughout the entire trial period;
- •Has a normal and regular menstrual cycle;
- •Clinically diagnosed with bacterial vaginosis (BV), defined as having at least three positive findings on Amsel's criteria, including the presence of clue cells (i.e., clue cells accounting for >20% of the total vaginal epithelial cells); and a Nugent score ≥ 7 points.
排除标准
- •Known allergy to any component of the investigational drug;
- •Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection;
- •Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;
- •Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);
- •History of complicated or recurrent VVC within 1 year prior to screening;
- •Known diagnosis of uterine fibroids or adenomyosis requiring intervention as assessed by the investigator;
- •Vaginal speculum examination at screening indicates significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);
- •History of significant diseases affecting the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may compromise subject safety;
- •Use of vaginal douching or other intravaginal treatments (e.g., products such as Jie Er Yin, Jie Yin Kang) within 72 hours prior to dosing or anticipated use during the trial period;
- •Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing;
- •Current use of long-acting contraceptive injections or oral contraceptives at screening;
- •History of gynecological surgery within 2 months prior to screening;
- •Positive virological tests for syphilis or HIV at screening;
- •Positive pregnancy test at screening; or history of pregnancy termination within 2 months prior to screening; or women of childbearing potential who, in the investigator's judgment, cannot use a medically approved and reliable contraceptive method from the time of signing the informed consent until 3 months after the last dose of the study drug;
- •Women who are pregnant or breastfeeding;
- •Participation in any other drug or medical device clinical trial within 3 months prior to dosing, involving the use of investigational drugs or devices; Any other medical condition that, in the investigator's judgment, may affect the assessment of the study.
研究组 & 干预措施
Vaginal Lactobacillus Dual Probiotic Capsules
Experimental
干预措施: Vaginal Lactobacillus Dual Probiotic Capsules (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure Rate
时间窗: Day 21 to Day 30
Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells)
次要结局
- Bacteriological Cure Rate(Day 21 to Day 30)
- Composite Cure Rate(Day 21 to Day 30)
- Clinical Cure Rate(Day 15 to Day 18)
- Bacteriological Cure Rate(Day 15 to Day 18)
- Composite Cure Rate(Day 15 to Day 18)
- Incidence of treatment-emergent adverse events (Safety Evaluation)(Through study completion, an average of 30 days)
- Incidence of treatment-related adverse events (Safety Evaluation)(Through study completion, an average of 30 days)
研究者
研究点 (1)
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