Real-world Evidence Study on the Performance and Safety of the Medical Device Halova Ovules in the Local Treatment of Vaginal Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 14
- 主要终点
- Rating and assessing of treatment-related Adverse Events
研究概览
简要总结
An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy treatment.
详细描述
The primary objective of this investigation is to evaluate the therapeutic performance and tolerability of Halova ovules in treating vaginal atrophy and restoring the natural lubrication of the vaginal mucosa.
The secondary objective of this clinical investigation are to evaluate the performance of the medical device by clinical examination, and the degree of patient satisfaction related to the intended use (Likert scale).
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 women, aged between 18 and above, in pre-menopause or menopause;
- •Adult women with atrophic vaginitis caused by estrogen hormone deficiency;
- •Adult women who have vaginal dryness as a result of contraceptive treatment or other disorders;
- •Subjects with a normal cervical cytology report, e.g. Negative for intraepithelial lesions or malignancy (NILM) or slightly changed to atypical squamous cells of undetermined significance (ASC-US) in the last 6 months;
- •Subjects willing to provide signed informed consent for participation in clinical investigation.
排除标准
- •Subjects with vulvar or cervical cancer.
结局指标
主要结局
Rating and assessing of treatment-related Adverse Events
时间窗: 30 days
The safety of Halova® ovules as measured by the rate of treatment-related adverse events, including serious adverse events (SAEs), in subjects participating in the clinical investigation
次要结局
- Patient Satisfaction(30 days)
- Clinical Performance(30 days)