ISRCTN11009040已完成未知
Randomised, prospective, open-label with control group clinical trial to investigate the efficacy and safety of the topical (intravaginal) application of the gel SAM vaginal gel” (class IIa medical device) through the regression rate of cervical smears ASC US, ASC H, LSIL, and HSIL and cervical lesions CIN 1 and CIN 2 and through the regression of the marker p16
Deflamed International s.r.o.0 个研究点目标入组 216 人开始时间: 2019年12月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33219482/ results (added 23/11/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34113633/ (added 14/06/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37373835/ (added 28/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female patients
- •2. Age 25 - 60 years
- •3. Histological diagnosis of CIN 1 or cytological ASC H, ASC US, LSIL associated with a positive cytological p16 or histological p16 test, or CIN 2 or HSIL
- •4. Signed informed consent
- •5. Negative pregnancy test
- •6. Suitable method of contraception during the treatment period for women of childbearing potential
排除标准
- •1. Oncological or immunological disease
- •2. Chronic viral disease (incl. hepatitis)
- •3. Immunosuppressive treatment
- •4. Pregnancy or breastfeeding
- •5. Known allergy to the gel or one of its components
- •6. Colposcopic finding suspicious of invasive disease
- •7. Simultaneous participation at another clinical trial
- •8. For CIN 2 patients, unsatisfactory colposcopy (i.e. the transformation zone and/or the lesion is not fully visible)
- •9. For CIN 1 patient, risk discrepancy with cytological finding (HSIL)
研究者
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