NL-OMON33950撤回2 期
Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle. - Effects of HPV-vaccination and imiquimod in Usual type VI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 98
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 99（—）
入选标准
- •- Histological proven usual type VIN, without invasion
- •- Previous treatment with imiquimod for 12-16 weeks with a partial response to
- •imiquimod treatment defined as a reduction in lesion size of 26%-99%
- •- The patient is willing to use a medically acceptable method of contraception throughout the study
- •- Age 18 and above
排除标准
- •- (Micro-)invasive carcinoma
- •- Pregnancy and/or breastfeeding
- •- Past history of vulvar cancer
- •- Differentiated (non HPV-related) VIN
- •- Other treatment of VIN or anogenital warts within 1 month of start trial
- •- Hypersensitivity to any components of the vaccine or cream formulation
- •- History of psoriasis or other inflammatory dermatosis of the vulva
- •- Immunodeficiency (e.g. HIV, corticosteroid use)
- •- Insufficient understanding of the Dutch Language
- •- Partial responders who are disease-free at study-entry due to other treatment of VIN
研究者
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Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN - Effects of HPV-vaccination and imiquimod in VIN patientsIn this trial, the efficacy of Gardasil combined with imiquimod in women with usual type Vulvar Intraepithelial Neoplasia is investigated.MedDRA version: 9.1Level: LLTClassification code 10047778Term: Vulvar cancer in situMedDRA version: 9.1Level: LLTClassification code 10066416Term: Vulvovaginal human papilloma virus infectionMedDRA version: 9.1Level: LLTClassification code 10046859Term: VaccinationMedDRA version: 9.1Level: LLTClassification code 10062059Term: Histology abnormalEUCTR2008-008251-42-NLErasmus MC
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