Medical Device Matuzalem Flavonoid Tea Extract Vaginal Ovule for the Correction of the Imbalance in the Vaginal Environment- Prospective, Multicentric, Two-arm, Randomized, Vehicle-controlled, Blinded, Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 14
- 主要终点
- Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
研究概览
简要总结
Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge), and fetor (odor)), and objective symptoms (pH, Nugent score) of bacterial vaginosis. An ovule containing only the vehicle (polyethylene glycol 3000 S) was used as a control. The study was blinded from the perspective of the subject, investigator, laboratory personnel and data analyst.
详细描述
The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days improves symptoms of intermediate vaginal flora and prevents the development of bacterial vaginosis.
Composite primary endpoint designed as a drop in the Nugent score, vaginal pH, or improvement of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm after 7 days of application and following 7 days after the application.
Secondary outcome measures were (1) Correction of the vaginal environment (as previously defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in each parameter separately; (3) change in individual subjective symptoms, (4) exploratory analysis of the microbial environment at each subject visit.
The study was approved and supervised by the National authority and Ethics committee and prospectively registered in the Czech national medical device trial registry RZPRO and the European medical device trial registry EUDAMED.
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)
盲法说明
blinded from the perspective of the participant, investigator, laboratory analyst and data analyst
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
- •premenopausal participants
- •disturbed vaginal environment
- •not in need of antibiotic or antimycotic treatment
- •participants were citizens of the Czech Republic
- •age between 18 and 55 years
- •either a vaginal pH > 4.5 or/and vaginal discomfort
- •able to follow the prescribed regimen
- •informed consents prior to any intervention, including diagnostic procedures.
排除标准
- •no vaginal bleeding of unknown aetiology
- •hypersensitivity
- •pregnancy
- •lactation
- •period during enrollment
- •antibiotics in the previous 30 days
- •treated with any products with similar indication
- •acute urogenital infection
- •diabetes mellitus
- •advanced oncologic disease
- •participant to other trial
- •Nugent score above 6
研究组 & 干预措施
Matuzalem
Tea extract vaginal ovule daily for 7 consecutive days
干预措施: Matuzalem ovule (Device)
Vehicle
Polyethylene glycol vaginal ovule daily for 7 consecutive days
干预措施: Vehicle ovule (Device)
结局指标
主要结局
Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after treatment completion
时间窗: following 7 days of the ovule daily application
Correction of the vaginal environment after 7 days of once-daily application of the ovule was defined as: a drop-in Nugent score to \< 4 and/or a drop in vaginal pH to \< 4.5, or a subjective improvement in at least 2 symptoms by at least 2 points on a 5-point scale in patients whose baseline pH was \< 4.5 and NS \< 4. Subjective symptoms: Pruritus, dolor, rubor, fluor and fetor reported by the patient on 5-point scale (0=no problem to 4=severe problem)
次要结局
- Exploratory analysis of the microbial environment after treatment completion: clue cells(following 7 days of the ovule daily application)
- Change in the subjective symptoms (questionnaire) after treatment completion(following 7 days of the ovule daily application)
- Change in the subjective symptoms (questionnaire) 7 days after treatment completion(7 days after the completion of the 7-day treatment)
- Change in the Nugent score alone 7 days after treatment completion(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: clue cells(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as pseudomycelia(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: squamous epithelial cells(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: squamous epithelial cells(7 days after the completion of the 7-day treatment)
- Composite endpoint (vaginal pH, Nugent score, subjective symptoms via questionnaire) after 7 days since treatment completion(7 days after the completion of the 7-day treatment)
- Change in the pH alone after treatment completion(following 7 days of the ovule daily application)
- Change in the Nugent score alone after treatment completion(following 7 days of the ovule daily application)
- Change in the pH alone after 7 days since treatment completion(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: mixed flora(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after treatment completion: yeast as pseudomycelia(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: mixed flora(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: Gram negative diplococci(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: parabasal epithelial cells(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: leukocytes(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram pos. cocci in chains(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Lactobacillus(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Gram negative diplococci(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: fibrous Lactobacillus(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: fibrous Lactobacillus(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: Gardnerella(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Gardnerella(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: leukocytes(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: Gram pos. cocci in chains(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Mobilincus(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: spirochetes(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: spirochetes(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: parabasal epithelial cells(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: yeast as blastospores(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: Lactobacillus(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after treatment completion: Mobilincus(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Leptotrichia(7 days after the completion of the 7-day treatment)
- Exploratory analysis of the microbial environment after treatment completion: Trichomonas vaginalis(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after treatment completion: yeast as blastospores(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after treatment completion: Leptotrichia(following 7 days of the ovule daily application)
- Exploratory analysis of the microbial environment after 7 days after treatment completion: Trichomonas vaginalis(7 days after the completion of the 7-day treatment)