EUCTR2012-004518-32-AT进行中（未招募）1 期
ITIC2 Trial - Topical Imiquimod versus Conization to Treat Cervical Intraepithelial Neoplasia: Randomised Controlled, Non-inferiority Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
入选标准
- •1)Women aged =18 years diagnosed with histologically verified CIN 3 and women aged = 30 years diagnosed with CIN 2
- •2)Satisfactory colposcopy
- •3)Signed informed consent
- •4)Negative pregnancy test
- •5)Appropriate contraception method for fertile women during active study period
- •6)Adequate compliance
- •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 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Adenocarcinoma in situ
- •2)History of previous conization
- •3)Malignant disease at the time of inclusion
- •4)Coploscopy suspicious for invasive disease
- •5)Pregnancy and lactation period
- •6)Known allergy or intolerance to IMQ
- •7)Contraindications to conization or IMQ
- •8)Symptoms of a clinical relevant disease
- •9)Known HIV infection
- •10)Evidence of a clinically significant immunodeficiency
- •11)Participation in another experimental, interventional, protocol
研究者
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