Use of Letrozole in the Treatment of Early Ectopic Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- levels of beta fraction of human chorionic gonadotropin (beta-hCG)
研究概览
简要总结
A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate
详细描述
This is a multicenter randomized clinical trial on the use of letrozole in the medical treatment of tubal ectopic pregnancy. Tubal ectopic pregnancy is an abnormal pregnancy in the fallopian tube. They occurred in about 8% of all pregnancies presenting to the emergency department. Methotrexate (MTX), administered systemically (intramuscularly), is a widely used medication for the treatment of unruptured tubal ectopic pregnancies and has been recommended as first-line treatment for early cases of ectopic pregnancy.
Letrozole is an aromatase inhibitor and can suppress estradiol levels. Some recent studies have shown that its use can be applied in cases of ectopic pregnancy.
The aim of this non-inferiority clinical trial is to verify that letrozole treatment is non-inferior to methotrexate treatment in women with early ectopic pregnancy who are hemodynamically stable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the outcome and the interventions, blinding was not considered an issue.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Diagnosis of ectopic pregnancy
- •Desire for reproduction
- •Ease of return
- •Undetermined pregnancy location with abnormal hCG growth
- •Presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hCG level ≤ 3000 mIU/ml
- •Absence of fetal cardiac activity
- •Average diameter of the adnexal mass ≤ 3.5 cm
- •Hemodynamically stable
- •No significant abdominal pain (i.e, < 6 on a visual analog scale)
排除标准
- •Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician)
- •Allergy to methotrexate or letrozole
- •A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or
- •≥ 85% in 4 days, or ≥ 95% in 7 days before randomization
- •Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)
- •Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min)
- •Hemoglobin <10 g/dl
- •Platelets <120.000/ml
- •Presence of heterotopic pregnancy
- •Do not wish to participate in the study.
研究组 & 干预措施
letrozole
Patients will receive 10mg of letrozole por 7 days.
干预措施: Letrozole tablets (Drug)
Methotrexate
Patients will receive a single intramuscular dose of 100 mg of methotrexate.
干预措施: Methotrexate Sodium (Drug)
结局指标
主要结局
levels of beta fraction of human chorionic gonadotropin (beta-hCG)
时间窗: weekly after the first day of intervention until reaching levels of beta-hCG below 5 milli-International unit per milliliter (assessed up to 5 months)"
On day 4 (D4) and 7(D7), beta-hCG levels will be measured. If a reduction equal or above 15% between D4 and D7 were observed, serum beta-hCG will be measured until reach levels \< 5 milli-International unit per milliliter (mIU/ml).
次要结局
未报告次要终点