A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 240
- 主要终点
- Time to clearance of high-risk human papillomavirus infection.
研究概览
简要总结
The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.
详细描述
Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% of sexually active women will become infected during their lifetime with human papillomavirus and 50% of these infections will be due to high-risk human papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer.
Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to be on acceptable method of birth control
- •Have a Pap smear result of LSIL or ASCUS
- •Is high risk HPV positive
排除标准
- •No evidence of high-grade disease or glandular abnormalities,
- •Complete visualization of all lesion margins and the transformation zone,
- •No uncontrolled significant medical illness or sexually transmitted infections,
- •Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
研究组 & 干预措施
1
干预措施: 851B (Drug)
2
干预措施: 851B (Drug)
3
干预措施: 851B (Drug)
4
干预措施: 851B (Drug)
5
干预措施: 851B (Drug)
6
干预措施: 851B (Drug)
7
干预措施: 851B (Drug)
8
干预措施: 851B (Drug)
9
干预措施: 851B (Drug)
10
干预措施: 851B (Drug)
11
干预措施: 851B (Drug)
结局指标
主要结局
Time to clearance of high-risk human papillomavirus infection.
时间窗: At each visit
次要结局
- Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.(Visits 1-3 as assigned by group)
- Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).(At each visit)
- Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).(At each visit)
- Time to progression of disease to precancer.(Visits 1-3 as assigned by group)
- Proportion of subjects with evidence of regression to normal cytology.(Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26).)