DRKS00030569尚未招募4 期
Efficacy of DeflaGyn® vaginal gel in the treatment of suspicious cervical smear findings, related histopathological diagnoses CIN1 and CIN2 and the hr-HPV status: a post marketing clinical follow-up study. - DEFLACIN-002
Exeltis Germany GmbH0 个研究点目标入组 70 人开始时间: 2022年10月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- Female
入选标准
- •1. Female premenopausal patients between 35 and 50 years
- •2. Cytologic diagnosis ASC-US, ASC-H, LSIL or HSIL
- •3. Histologic Diagnosis of CIN1 or CIN2
- •4. Positive for hr-HPV
- •5. Written Informed Consent
排除标准
- •1. Oncological or immunological disease
- •2. Chronic viral disease
- •3. Immunosuppressive treatment
- •4. Pregnancy
- •5. Patients who are postmenopausal
- •6. Known Allergy to the gel or one of its components
- •7. Colposcopic finding conspicuous of invasive disease
- •8. Unsatisfactory colposcopy
- •9. For CIN1 patients: risk discrepancy with cytological findings (e.g. HSIL; ASC-H)
- •10. Benign or malignant gynecological changes of the vulva
- •11. Simultaneous participation at another clinical trial or during participation during the preceding 6 months
研究者
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