Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Number of patients with no HPV infection
研究概览
简要总结
Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection.
In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available.
Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time.
The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pathologic Pap smear
- •positive "high risk" HPV DNA test
- •positive colposcopy examination
排除标准
- •patients who had undergone wart therapy in the previous six months
- •pregnancy
- •invasive disease
- •immunosuppression
- •previous HPV vaccination
结局指标
主要结局
Number of patients with no HPV infection
次要结局
未报告次要终点