PACTR202401582817992Other1 期
CPM 22120: Safety of adjuvant, self-administered intravaginal 5-fluorouracil (5-FU) cream following cervical intraepithelial neoplasia grade 2 and 3 (CIN2/3) treatment among HIV-positive women in Kenya: A pilot study
C OBGYN Department0 个研究点目标入组 12 人开始时间: 2024年1月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- 入组人数
- 12
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
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •1.HIV-positive women (confirmed with serum antibody testing)
- •2.Age 18 years – 49 years at enrollment
- •3.Documentation of a biopsy-confirmed CIN2 or CIN3
- •4.Within 4-12 weeks after primary treatment (either cryotherapy, thermal ablation, or loop electrosurgical excision procedure (LEEP)) for CIN2 or CIN3
- •5.Negative pregnancy test at screening
- •6.Agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation – plus condoms) during the study duration, if of childbearing age. Condoms can be male or female condoms
- •7.Ability to understand and willingness to sign (or assent when applicable) informed consent
排除标准
- •1.Unwilling or unable to use birth control during participation in the study
- •2.History of invasive cervical cancer
- •3.Known allergy to 5-Fluorouracil
- •4.History of total hysterectomy
- •5.Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
- •6.Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
研究者
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