Evaluation of Different Doses of Letrozole in Ectopic Pregnancy (letrezole)
2022年1月15日 更新者:Mohamed Ali Alabiad, MD、Zagazig University
Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.
研究概览
详细说明
Letrozole, an aromatase inhibitor, has recently been introduced as favorable medical treatment for ectopic pregnancy.
We aimed at evaluating the effects of different doses of letrozole for induction of abortion Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups.
Group I: The control group that contained women who were undergoing laparoscopic salpingectomy, Group II: Patients who received letrozole (5 mg d-1) for 10 d, and Group III: Patients who received letrozole (10 mg d-1) for 10 d.
After that, the human chorionic gonadotropin (β-hCG) levels were determined for the first day and after 11 d of treating.
letrozole (10 mg d-1) markedly reduced the receptors of estrogen and progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked apoptosis in the placenta tissue.
The utilization of letrozole at a dose of 10 mg d-1 for inducement of abortion typically results in a substantial high-successful rate without any severe side effects.
研究类型
介入性
注册 (实际的)
60
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
-
-
Sharkia
-
Zagazig、Sharkia、埃及、14150
- Mohamed ALI Alabiad
-
-
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
19年 至 35年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Diagnosed ectopic pregnancy was by
- Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
- β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).
Exclusion Criteria:
- Patients had contraindications for letrozole
- Patients with any systemic disease ( diabetes, hypertension, ....)
- Patients with b-hCG levels >3,000 mIU/mL
- Patients with hemoglobin level <10 g/dL,
- Patients with platelets count <150,000/mL,
- Patients with elevated liver enzymes,
- Patients with elevated blood urea, or serum creatinine
- The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity
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:治疗
- 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 |
---|---|
有源比较器:Control group I (GI)
Patients who were undergoing surgical treatment
|
laparoscopic salpingectomy
|
实验性的:low dose letrozole group II (GII)
patients who were medically treated with 5 mg of letrozole
|
GI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III)
其他名称:
|
实验性的:High dose letrozole group (GIII)
patients who were medically treated with 10 mg of letrozole using
|
GI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III)
其他名称:
|
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 |
---|---|---|
β-hCG level
大体时间:The β-hCG levels were assessed on the 1st of treatment
|
A quantitative human chorionic gonadotropin
|
The β-hCG levels were assessed on the 1st of treatment
|
β-hCG level
大体时间:The β-hCG levels were assessed on the 11th day of treatment
|
A quantitative human chorionic gonadotropin
|
The β-hCG levels were assessed on the 11th day of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Complete blood count (CBC)
大体时间:Assessed on the 1st day of treatment
|
Complete blood count
|
Assessed on the 1st day of treatment
|
Alanine Amino Transferase (ALT)
大体时间:Assessed on the 1st and 11th day of treatment
|
Liver enzyme
|
Assessed on the 1st and 11th day of treatment
|
Aspartate aminotransferase (AST)
大体时间:Assessed on the 1st and 11th day of treatment
|
Liver enzyme
|
Assessed on the 1st and 11th day of treatment
|
Serum creatinine
大体时间:Assessed on the 1st and 11th day of treatment
|
Renal function test
|
Assessed on the 1st and 11th day of treatment
|
Blood urea
大体时间:Assessed on the 1st and 11th day of treatment
|
Renal function test
|
Assessed on the 1st and 11th day of treatment
|
Complete blood count (CBC)
大体时间:Assessed on the 11th day of treatment
|
Complete blood count
|
Assessed on the 11th day of treatment
|
Alanine Amino Transferase (ALT)
大体时间:Assessed on the 11th day of treatment
|
Liver enzyme
|
Assessed on the 11th day of treatment
|
Aspartate aminotransferase (AST)
大体时间:Assessed on the 11th day of treatment
|
Liver enzyme
|
Assessed on the 11th day of treatment
|
Serum creatinine
大体时间:Assessed on the 11th day of treatment
|
Renal function test
|
Assessed on the 11th day of treatment
|
Blood urea
大体时间:Assessed on the 11th day of treatment
|
Renal function test
|
Assessed on the 11th day of treatment
|
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:Ahmed I Heraiz, MD、Zagazig University
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 (实际的)
2020年12月15日
初级完成 (实际的)
2021年11月20日
研究完成 (实际的)
2022年1月1日
研究注册日期
首次提交
2022年1月4日
首先提交符合 QC 标准的
2022年1月15日
首次发布 (实际的)
2022年1月20日
研究记录更新
最后更新发布 (实际的)
2022年1月20日
上次提交的符合 QC 标准的更新
2022年1月15日
最后验证
2022年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- LETROZOLE ON ECTOPIC PREGNANCY
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
Table Statistical analysis Master sheet raw data (excel sheet)
IPD 共享时间框架
the data will become available after one month from the approval and will be available for three months
IPD 共享访问标准
you can send a Data request email to Dr: Mohamed at drno99@yahoo.com
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
研究数据/文件
-
研究协议
信息评论:you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
-
统计分析计划
信息标识符:drno99@yahoo.com信息评论:you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
-
知情同意书
信息评论:you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
-
个人参与者数据集
信息评论:you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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