Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- β-hCG level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Control group I (GI)
Patients who were undergoing surgical treatment
干预措施: laparoscopic salpingectomy (Procedure)
low dose letrozole group II (GII)
patients who were medically treated with 5 mg of letrozole
干预措施: Letrozole tablets (Drug)
High dose letrozole group (GIII)
patients who were medically treated with 10 mg of letrozole using
干预措施: Letrozole tablets (Drug)
结局指标
主要结局
β-hCG level
时间窗: The β-hCG levels were assessed on the 11th day of treatment
A quantitative human chorionic gonadotropin
次要结局
- Complete blood count (CBC)(Assessed on the 11th day of treatment)
- Blood urea(Assessed on the 11th day of treatment)
- Alanine Amino Transferase (ALT)(Assessed on the 11th day of treatment)
- Aspartate aminotransferase (AST)(Assessed on the 11th day of treatment)
- Serum creatinine(Assessed on the 11th day of treatment)
研究者
Mohamed Ali Alabiad, MD
Principal Investigator
Zagazig University