CTIS2024-513969-39-00进行中（未招募）1 期
Randomized, placebo-controlled, double-blind study to evaluate 2LPAPI® efficacy on the clearance of genital HR-HPV infections (PAPION study) - LLB-2017-01
abo'Life Belgium0 个研究点目标入组 284 人开始时间: 2024年4月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 284
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Women between 25 and 45 years old; - Women of childbearing age under effective contraception; - Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology - Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC, LSIL+ASC-H results or current diagnosis of CIN I at the histology; - Patient with HR-HPV diagnosis at the current cervical collection; - Patient reporting a current stable sexual relationship (steady sexual partner for the duration of the study); - Patient having the ability to understand and respect the constraints of the study; - Signature of the Informed Consent Form.
排除标准
- •- Pregnant or breastfeeding women; - Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology; - Patient having received HPV vaccination in the last month; - Patient previously subject to a total hysterectomy; - Patient under immunotherapy treatment (including immunosuppressive treatments) or micro-immunotherapy received in the last six months; - Patient with known lactose intolerance; - Patient who has participated in a clinical study in the last three months; - Patient not sufficiently motivated to engage in a 12-month follow-up, or likely to travel or move before the end of the study; - Patient with severe immune deficiency requiring long-term treatment (*) or under chemotherapy or radiotherapy; - Patient under listed homeopathic or phytotherapy treatment (see list in the protocol); - Patient using or addicted to recreational drugs. (*) important renal or respiratory failure,
研究者
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