Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- vaginal bacterial counts
研究概览
简要总结
The study is a multidisciplinary research project and has two main aims:
- To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis on its effect on the vaginal microenvironment after different durations of use: the vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and immune activation in the vagina
- To investigate the feasibility, acceptability and adherence to vaginal ring use in Rwandan women, including attitudes towards a future multi-purpose vaginal ring for prevention of both pregnancy and sexually transmitted infections (STI).
详细描述
- An integrated study design
This clinical study combines a clinical safety evaluation of the contraceptive vaginal ring (CVR) with social science research on acceptability and adherence of ring use in Rwandan women.
The clinical part of the study assesses the general safety of the contraceptive ring including the effect on the vaginal microbiome, genitourinary symptoms and signs and clinical adverse events. In addition the clinical part of the study aims to understand better the possible biofilm formation and to explore the impact of the ring on the microbiome and inflammation in the vagina.
The social science component consists of a combination of a mixed-methods research including In-depth Interviews (IDIs), Focus Group Discussions (FGDs), questionnaires, and (if funding permits) audio computer-assisted self-interviewing (ACASI). 2. Clinical study design
This is an open label single-centre cohort study with the NuvaRing®. A total of 120 Human Immunodeficiency Virus(HIV)-negative women will be randomized to an intermittent regimen or a continuous regimen of ring use and will be followed for maximum 14 weeks, to determine general safety of the ring in the African context, and to determine differences in the vaginal microbiome and vaginal inflammation before and after use of a contraceptive vaginal ring (CVR). Qualitative research for the social science component will be performed to address the acceptability and adherence of intermittent or continuous CVR use in more depth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give informed consent/assent, according to national guidelines
- •Female who self-reports to be sexually active (meaning at least one penetrative vaginal coital act per month for the last 3 months prior to screening)
- •Between 18 to 35 years old, inclusive
- •Currently in good physical and mental health
- •Interested in initiating hormonal contraception
- •Able and willing to participate in the study as required by the protocol, this includes willing to undergo HIV testing and use a NuvaRing®
- •HIV negative at screening as confirmed by rapid HIV testing
排除标准
- •Currently using a modern contraceptive method other than barrier methods
- •Use of a hormonal contraceptive method in the three months prior to the screening visit
- •Currently using antimicrobial medication
- •Pregnant on urine pregnancy test
- •History of cardiovascular disease
- •History of hysterectomy or genital tract surgery (including cervical polypectomy, dilatation and curettage, hysteroscopy, or laparoscopy) in the three months prior to the screening visit
- •History of complications with hormonal contraception or with contra indications for the use of hormonal contraceptives such as:
- •History or known predisposition for venous thrombosis
- •History of migraine with focal neurological symptoms
- •Diabetes mellitus with vascular involvement
- •History of pancreatitis or severe hepatic disease
- •Known or suspected hypersensitivity to any of the excipients of NuvaRing®
- •History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, incontinence or urge incontinence, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction
- •Participating in other clinical studies involving investigational products
- •Currently breastfeeding
- •Currently a smoker
结局指标
主要结局
vaginal bacterial counts
时间窗: 5 months
Changes from baseline (pre-ring use) in vaginal bacterial counts and in the absence/presence of bacterial vaginosis-related bacteria as measured with quantitative real time polymerase chain reaction (PCR).
次要结局
- Incidence of adverse and serious adverse experiences(5 months)
- Changes in phenotype of bacterial vaginosis-related bacteria(5 months)
- Presence or absence of a biofilm on the contraceptive vaginal rings (CVRs)(5 months)
- Changes in inflammatory cytokines concentrations in Cervicovaginal lavage (CVLs)(5 months)