Emergency Contraception and Body Weight: Pilot Study
2017年9月22日 更新者：Alison Edelman、Oregon Health and Science University
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG).
This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight.
The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.
研究概览
详细说明
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.
We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
研究类型
介入性
注册 (实际的)
10
阶段
- 第四阶段
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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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University
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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
18年 至 35年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Subjects are between the ages of 18 and 35
- Subjects are in good general health
- Subjects have regular menstrual cycles (between 21 and 35 days)
- Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).
Exclusion Criteria:
- Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
- Impaired liver or renal function
- Actively seeking or involved in a weight loss program (must be weight stable)
- Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception
- Current use of drugs that interfere with metabolism of sex steroids
- Smokers.
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
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Normal BMI ECx1
5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
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At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours).
After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
其他名称：
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有源比较器：Obese BMI ECx1
5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
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At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours).
After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
其他名称：
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有源比较器：Obese BMI ECx2
5 obese women (BMI >30 kg/m2) taking 3mg LNG
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At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours).
For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
大体时间：Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
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Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
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Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
大体时间：Follicular phase of menstrual cycle
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Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
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Follicular phase of menstrual cycle
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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：Alison Edelman, MD, MPH、Oregon Health and Science University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2015年2月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年8月1日
研究注册日期
首次提交
2015年3月27日
首先提交符合 QC 标准的
2015年4月2日
首次发布 (估计)
2015年4月3日
研究记录更新
最后更新发布 (实际的)
2017年10月25日
上次提交的符合 QC 标准的更新
2017年9月22日
最后验证
2017年9月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
PI acknowledges willingness to share data and materials with other investigators through established means.
Data will be presented via presentation and publication.
Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at OHSU.
OHSU complies with NIH policy on Sharing Research Data.
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.
ECx1的临床试验
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Oregon Health and Science UniversityNational Institutes of Health (NIH)完全的