Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy

Conditions
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Ectopic Pregnancy

Intervention / Treatment
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* Drug: Letrozole tablets
* Procedure: laparoscopic salpingectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group I (GI)<br>Patients who were undergoing surgical treatment | Procedure: laparoscopic salpingectomy<br>* laparoscopic salpingectomy<br>|
| Experimental: low dose letrozole group II (GII)<br>patients who were medically treated with 5 mg of letrozole | Drug: Letrozole tablets<br>* 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)<br>* Other names: Femara;|
| Experimental: High dose letrozole group (GIII)<br>patients who were medically treated with 10 mg of letrozole using | Drug: Letrozole tablets<br>* 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)<br>* Other names: Femara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| β-hCG level | A quantitative human chorionic gonadotropin | The β-hCG levels were assessed on the 1st of treatment | 
| β-hCG level | A quantitative human chorionic gonadotropin | The β-hCG levels were assessed on the 11th day of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood count (CBC) | Complete blood count | Assessed on the 1st day of treatment | 
| Alanine Amino Transferase (ALT) | Liver enzyme | Assessed on the 1st and 11th day of treatment | 
| Aspartate aminotransferase (AST) | Liver enzyme | Assessed on the 1st and 11th day of treatment | 
| Serum creatinine | Renal function test | Assessed on the 1st and 11th day of treatment | 
| Blood urea | Renal function test | Assessed on the 1st and 11th day of treatment | 
| Complete blood count (CBC) | Complete blood count | Assessed on the 11th day of treatment | 
| Alanine Amino Transferase (ALT) | Liver enzyme | Assessed on the 11th day of treatment | 
| Aspartate aminotransferase (AST) | Liver enzyme | Assessed on the 11th day of treatment | 
| Serum creatinine | Renal function test | Assessed on the 11th day of treatment | 
| Blood urea | Renal function test | Assessed on the 11th day of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LETREZOLE, Ectopic pregnancy, Induced abortion