Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
研究概览
简要总结
This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, age 18-50 years
- •Willing and able to provide written informed consent
- •HIV-uninfected and otherwise healthy
- •Willing to abstain from sexual activity and from use of vaginal products while participating in the study
- •Currently using oral contraceptives for pregnancy prevention
- •Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study
排除标准
- •History of allergy to TMC120 or to the constituents of the vaginal ring
- •History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months
- •History of genital tract surgery within the last month
- •Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
- •Currently or within one month of participating in any other clinical research study
- •Current vulvar or vaginal symptoms / abnormalities that could influence the study results
- •Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
- •Current diagnosis of any genital infection
- •Smoking more than 10 cigarettes / day
结局指标
主要结局
Safety and tolerability of seven-day use of a vaginal ring containing dapivirine (TMC120).
Assess dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma during and after seven-day use of a vaginal ring containing dapivirine (TMC120).
次要结局
未报告次要终点