A Randomized, Double-blind, Multi-centre, Placebo Controlled Phase II Clinical Study to Evaluate the Efficacy, Tolerance and Safety of an Aqueous Gel Containing an Antiviral, Directly Applied on the Cervix Exhibiting High Grade Intraepithelial Lesion.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Efficacy at week 12: change of histological and cytological parameters (success or not)
研究概览
简要总结
The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.
详细描述
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.
This clinical study is aimed at:
- to evaluate the efficacy of a gel with antiviral directly applied on the cervix exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?
- to evaluate the safety and tolerance after local application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 days before inclusion
- •No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)
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 use of drugs interfering with renal function
- •Current use of oncologic treatment
- •Current use of immune treatment
- •Current use of anti-viral treatment
- •Current vaginal application of drugs or cosmetics
- •Prior treatment with the antiviral on the cervix
- •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
研究组 & 干预措施
Treatment group
干预措施: C1 (Drug)
Placebo group
干预措施: C1 (Drug)
结局指标
主要结局
Efficacy at week 12: change of histological and cytological parameters (success or not)
时间窗: 12 weeks
Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.
Efficacy at week 28: recurrence rate
时间窗: 28 weeks
The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.
Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)
时间窗: during 30 weeks
Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.
次要结局
- Virological status (infection)(during 30 weeks)
- Changes in lesion (colposcopic changes)(during 30 weeks)