A Randomized, Controlled, Comparative Study of a Levonorgestrel Intrauterine System for the Prevention of Endometrial Cancer in Patients Aged 40-50 With BMI Greater Than 35
2009年12月10日 更新者:University of Medicine and Dentistry of New Jersey
Endometrial (uterine) cancer affects over 40,000 women each year in the United States.
At this time there are no medications to prevent endometrial cancer.
Women who are heavy are at increased risk of this cancer.
Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates.
Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne.
A device called Mirena has a type of progesterone in it.
Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects.
In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40.
(BMI is a measure of obesity.
Normal is less than 25.)
They will be randomized to either observation or treatment.
The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year.
All of the women will have endometrial biopsies and blood work at the beginning and end of the study.
All of the women will have an ultrasound at the beginning of the study.
The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent.
The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer.
A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining.
研究概览
详细说明
Endometrial (uterine) cancer affects over 40,000 women each year in the United States.
At this time there are no medications to prevent endometrial cancer.
Women who are heavy are at increased risk of this cancer.
Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates.
Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne.
A device called Mirena has a type of progesterone in it.
Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects.
In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40.
(BMI is a measure of obesity.
Normal is less than 25.)
They will be randomized to either observation or treatment.
The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year.
All of the women will have endometrial biopsies and blood work at the beginning and end of the study.
All of the women will have an ultrasound at the beginning of the study.
The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent.
The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer.
A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining.
研究类型
观察性的
注册 (预期的)
44
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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New Jersey
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New Brunswick、New Jersey、美国、08901
- Cancer Institute of New Jersey
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
概率样本
研究人群
Levonorgestrel IUD, Prevention of Endometrial Cancer, Patients Aged 35-50, BMI > 30
描述
Inclusion:
Woman between 40-50 years of age. Body mass index (BMI) ³ 35. Benign (no hyperplasia or cancer) endometrial biopsy prior to randomization Has an intact uterus
Exclusion:
Present infection with gonorrhea or chlamydia or within the last 5 years. Bacterial vaginosis that does not respond to one course of antibiotics. History of pelvic inflammatory disease in the last 5 years. Patients who are pregnant or who desire to become pregnant Does not desire fertility History of deep venous thrombosis or pulmonary embolus
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Allison Wagreich, MD、Rutgers, the State University of New Jersey
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年2月1日
初级完成 (实际的)
2006年6月1日
研究完成 (实际的)
2006年6月1日
研究注册日期
首次提交
2005年9月8日
首先提交符合 QC 标准的
2005年9月11日
首次发布 (估计)
2005年9月12日
研究记录更新
最后更新发布 (估计)
2009年12月11日
上次提交的符合 QC 标准的更新
2009年12月10日
最后验证
2009年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Levonorgestrel intrauterine system的临床试验
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SpineSave AG尚未招聘脊椎关节炎 | 腰椎不稳 | 退行性脊椎滑脱 | 退行性腰椎管狭窄症 | 椎间盘病 | 小关节关节病
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Archus Orthopedics, Inc.未知腰背疼痛 | 脊柱疾病 | 腰椎管狭窄症 | 椎管狭窄 | 腰椎滑脱 | 腿痛
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Hadassah Medical Organization未知