EUCTR2008-006208-52-DE进行中（未招募）不适用
Mono-centre, open-label study to investigate the multi-dose pharmacokinetics, efficacy and safety of Interferon alpha-2b Cream in women with a history of cytological diagnosed Pap IIID, with a confirmed histological diagnosis of CIN I or II, and of confirmed HPV+ status - Interferon alpha-2b kinetics in Pap IIID women
Helix BioPharma Cooperation0 个研究点开始时间: 2009年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Female, pre-menopausal subjects aged 18 to 45 years inclusive
- •- Cytological diagnosis of Pap IIID (Munich nomenclature II) not older than 12 months
- •- Mild cervical dysplasia (CIN I) or moderate cervical dysplasia (CIN II) confirmed by histology
- •- HPV+ status confirmed by Hybrid Capture® 2 HPV Deoxyribonucleic Acid (DNA)-Test (Digene®)
- •- Subjects must be on stable hormonal contraception, which guarantees 29 consecutive days without menstruation
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- No Ccytological diagnosis of Pap IIID within the last 12 months or at screening
- •- Severe dysplasia (CIN III), carcinoma in situ or invasive carcinoma
- •- History of abnormal Pap smears higher than Pap IIID
- •- History of or current internal or external urogenital warts
- •- History of frequently recurrent or current sexually-transmitted infection(s) or bacterial vaginosis
- •- History or presence of other malignancies
- •- History or presence of an immune-compromising disease, or a positive Human Immunodeficiency Virus (HIV) test result at screening
- •- History of Hepatitis B or C, or a positive Hepatitis B or Hepatitis C test result at screening
- •- Any other treatment of the cervical lesion during study participation (e.g. conization, laser ablation)
- •- Contraindication for the use of hormonal contraceptives
研究者
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