Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
研究概览
简要总结
To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥18-40 year old women
- •BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months
- •Willing to use the NuvaRing as directed
- •Not intending or wishing to become pregnant over the course of the study
- •Capable of providing written informed consent
排除标准
- •Current pregnancy
- •Desire/intent to become pregnant over the course of the study
- •Women who are less than 6 weeks postpartum
- •Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years
- •Current IUD
- •Unable to comprehend consent material because of language barrier or psychological difficulty
研究组 & 干预措施
Cyclic NuvaRing CVR Use
CVR use for 3 weeks, remove for 1 week, then replace
干预措施: NuvaRing (Drug)
Continuous NuvaRing CVR Use
CVR use for 4 weeks, then replace
干预措施: NuvaRing (Drug)
结局指标
主要结局
Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
时间窗: Up to 8 months
Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)
次要结局
- Number of Visits With BV(Up to 8 months)
研究者
Christine Johnston
Assistant Professor, Medicine/Division of Allergy and Infectious Diseases
University of Washington