Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
研究概览
简要总结
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).
Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.
The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Non-pregnant, healthy females who are seeking an IUD for contraception
- •Age 18-40 years, inclusive at the time of enrollment
- •History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
- •Willing and able to sign the informed consent and to comply with the study protocol
- •Inclusion criteria for healthy control subjects:
- •Non-pregnant, healthy females
- •Age 18-40 years, inclusive at the time of enrollment
- •History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
- •Willing and able to sign the informed consent and to comply with the study protocol
- •Prior surgical sterilization or heterosexually abstinent
排除标准
- •Use of any hormonal or intrauterine contraceptive method within the past two months
- •Use of DMPA within the past 10 months
- •Any of the following within the past two months:
- •Pregnancy or breastfeeding
- •Surgery/biopsy of the vulva, vagina, or cervix
- •History of STI
- •New sexual partner
- •Evidence of vaginal/pelvic infection on screening
- •Abnormal wet mount (see description above)
- •Pelvic exam findings clinically consistent with infection
- •Positive screen for Gc, Ct, or HIV (will be excluded post randomization)
- •Active HSV/ulcerative disease in the genital tract or perineum
- •History of immunosuppression (diabetes, HIV, chronic steroid use)
- •Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
- •Use of any systemic or vaginal steroid or antibiotic within the past 30 days
- •Vaginal or anal intercourse within 1 week of sample collection
- •Heterosexual vaginal intercourse since last menses without condom use
- •History of hysterectomy
- •History of malignancy in the uterus or cervix
- •Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
- •Allergy to copper and/or intolerance to levonorgestrel
研究组 & 干预措施
Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
干预措施: IUD placement (Drug)
Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
干预措施: Levonorgestrel IUD (Drug)
Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
干预措施: IUD placement (Drug)
Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
干预措施: Copper T380A IUD (Drug)
结局指标
主要结局
%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
时间窗: 2 months
Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety
次要结局
- Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis(2 Months)
- Change in Vaginal Flora(2 Months)
研究者
Sharon Achilles
Assistant Professor
University of Pittsburgh