EUCTR2010-023271-26-BE进行中（未招募）1 期
A randomized, double-blind, multi-centre, placebo controlled phase II clinical study to evaluate the efficacy, tolerance and safety of an aqueous gel containing 2% (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3) - Colvir-Phase II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-women aged between 18 and 50 years old;
- •-informed consent signed;
- •-cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 preceding days;
- •-no sexual activity or proved sterility or use of effective mechanical, hormonal or intrauterine contraception (except vaginal ring Nuvaring, diaphragm and spermicide).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 132
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-invasive or microinvasive cervical neoplasia;
- •-pregnancy or breast feeding;
- •-subtotal hysterectomy;
- •-current renal impairment;
- •-current immune disorder including serology HIV+;
- •-current systemic use of drugs interfering with renal function (intravenous contrast media, aminoglycosides, glycopeptides)
- •-current systemic treatment for any cancer;
- •-current systemic use of treatment interfering with immunity (table 2), except vaccines;
- •-current systemic use of anti-viral treatment (table 2)
- •-current vaginal application of drugs or cosmetics;
- •-previous topical treatment of the cervix by cidofovir;
- •-local or general condition incompatible with the experimental treatment in the opinion of the principal investigator;
- •-current or recent participation to another experimental study during the last 3 months before the screening visit.
研究者
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