Real-world Performance and Safety of Cerviron® Medical Device in the Treatment of Various Types of Vaginitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 10
- 主要终点
- Safety of the medical device
研究概览
简要总结
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis.
A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.
详细描述
This study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of Cerviron® ovules in the treatment and management of various types of vulvovaginitis. The study collected clinical data from 28 different specialized gynecology clinical facilities. The study was conducted between May 20, 2021 and August 31, 2021.
The primary objective of this study was to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vulvovaginitis, but also to confirm its performance both on symptoms relief and as a user-friendly device. The secondary objective of this study was to assess the performance of the medical device by clinical exam and patients' degree of satisfaction. The study design consisted of 3 or 4 visits over 90 ± 3 days. Cerviron® ovules were applied intravaginally, once per day, on the first day after menstruation and for 15 days during 3 consecutive months.
Data of 111 women aged between 20 and 70 years were analyzed, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with anti-infectious therapy.
The symptoms recorded in the medical charts were followed to determine the performance of the medical device during the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females with a diagnosis of infectious or non-infectious vaginitis and treated with Cerviron® with or without anti-infectious treatment for at least three months:
- •Negative result for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis.
排除标准
- •Subjects with diagnosed abnormal genital bleeding;
- •Subject with vulvar, vaginal or cervical cancer;
- •Subjects with other inflammatory gynecological conditions.
结局指标
主要结局
Safety of the medical device
时间窗: 3 months
the number of possible adverse Number of reactions observed during the treatment
次要结局
- Improvement in vaginal irritation(3 months)
- Measurement of vaginal pH(3 months)
- Improvement in the vaginal discharge aspect(3 months)
- Improvement in the association of vaginal symptoms (burn and pain)(3 months)