Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 10
- 主要终点
- Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+
研究概览
简要总结
Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.
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
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 35 and 50 years of age (inclusive)
- •Women who will be scheduled to undergo an RRSO or RRs
- •Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
- •Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
- •Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)
排除标准
- •Any medical contraindication to use of a Mirena® IUD, including:
- •Pregnancy (a pregnancy test is required prior to study entry)
- •Known uterine anomaly that distorts the shape of the uterine cavity
- •Acute pelvic inflammatory disease
- •Postpartum endometritis or endometrial infection
- •Known or suspected uterine or cervical neoplasia
- •Known history or suspected breast cancer or other progestin-sensitive cancer
- •Uterine bleeding of unknown etiology.
- •Untreated acute cervicitis, vaginitis, or other lower genital tract infections
- •Acute liver disease or liver tumor (benign or malignant)
- •Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
- •Positive pregnancy test
- •Breastfeeding
- •Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD
结局指标
主要结局
Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+
时间窗: 1 year
Women will be deemed evaluable for this primary outcome if they successfully underwent placement of the Mirena® IUD, received a RRSO or RRS as planned, and had a P4 value ≤1 ng/ml.
次要结局
未报告次要终点