NCT01448291Unknown4 期
The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) after 3 months of NuvaRing® use
研究概览
简要总结
It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of inflammation.
Hypothesis:
The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in the vagina.
Specific aims of this study are to:
- Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use
- Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration before and after treatment with NuvaRing®
- Monitor for changes in the Nugent score before and after NuvaRing® use
- Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use
- Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use
Methods This is a prospective, open-label, nonrandomized study. Participants will serve as their own controls. The Clinical Research Center of Eastern Virginia Medical School, Norfolk, Virginia, U.S.A. will be the only study site.
详细描述
- To complete specific aim #1, the investigators will use commercially available elisa kits to measure human defensins, inflammatory cytokines, and anti-inflammatory cytokines in vaginal fluid washings collected before and after use of NuvaRing.
- To complete specific aim #2, the investigators will collect biopsies of the uterine cervix before and after NuvaRing use. Specimens will undergo histopathological measures for overall appearance, epithelial integrity, epithelial thickness, leukocyte infiltration, congestion, and edema. The investigators will quantitate the number of CD45+ and NFkB+ cells using immunohistology in the cervical epithelium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women (age 18 - 45) interested in using NuvaRing® for contraception for 3 or more months, and women who are not at risk for pregnancy (i.e. abstinent, tubal sterilization, partner with vasectomy)
- •Women with a normal menstrual cycle (21-35 days) for the past three cycles
- •Women with normal pelvic anatomy (by physical exam)
- •Negative urine pregnancy test
- •Normal pap smear within the past 12 months
排除标准
- •Current breastfeeding
- •Less than 6 weeks post partum
- •Current IUD or Implanon use
- •Depot Medroxyprogesterone Acetate use within the past 6 months
- •Current diagnosis of uterine infection
- •Use of hormonal contraception within the past 30 days
- •Current cervical dysplasia
- •Chronic immune suppression
- •Chronic use of immune suppressors such as steroids
- •Chronic antibiotic use
- •Diabetes or fasting blood glucose >105
- •Hysterectomy
- •Uncontrolled hypertension (systolic BP≥140/ diastolic BP≥ 90)
- •Migraine headaches complicated by aura or focal neurologic deficits
- •Standard contraindications to combined oral contraceptive use (thrombophilia, active liver disease, active deep venous thrombosis, history of thrombosis)
- •Use of tobacco products ≥ 35 years of age
- •Two or more symptomatic genital herpes simplex virus (HSV) outbreaks in past 12 months
- •Human immunodeficiency virus
- •Vulvovaginal candidiasis
- •Trichamonas vaginalis
- •Neisseria gonorrhea
- •Chlamydia trachomatis
- •Bacterial vaginosis
- •Nugent scores of 4 or greater
- •Use of any other study medication within the past 30 days
研究组 & 干预措施
Nuvaring
Experimental
This is a single-group study in which data points after use of the etonogestrel/ethinyl estradiol vaginal ring will be compared to baseline.
干预措施: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring (Drug)
结局指标
主要结局
Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) after 3 months of NuvaRing® use
时间窗: 3 months
次要结局
- Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing®(Baseline and 3 months)
研究者
Thomas Kimble
Assistant Professor
Eastern Virginia Medical School
研究点 (1)
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