Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

Phase 4

Completed

• Conditions: Ectopic Pregnancy
• Interventions: Drug: Letrozole tablets; Procedure: laparoscopic salpingectomy

• Registration Number: NCT05198141
• Lead Sponsor: Zagazig University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-15
• Primary Completion: 2021-11-20
• Status Verified: 2022-01
• Study Completion: 2022-01-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-15
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose letrozole group (GIII)	Letrozole tablets	patients who were medically treated with 10 mg of letrozole using
Control group I (GI)	laparoscopic salpingectomy	Patients who were undergoing surgical treatment
low dose letrozole group II (GII)	Letrozole tablets	patients who were medically treated with 5 mg of letrozole

Primary Outcome Measures

Name	Time	Method
β-hCG level	The β-hCG levels were assessed on the 11th day of treatment	A quantitative human chorionic gonadotropin

Secondary Outcome Measures

Name	Time	Method
Complete blood count (CBC)	Assessed on the 11th day of treatment	Complete blood count
Blood urea	Assessed on the 11th day of treatment	Renal function test
Alanine Amino Transferase (ALT)	Assessed on the 11th day of treatment	Liver enzyme
Aspartate aminotransferase (AST)	Assessed on the 11th day of treatment	Liver enzyme
Serum creatinine	Assessed on the 11th day of treatment	Renal function test

Trial Locations

Locations (1)

Mohamed ALI Alabiad; 🇪🇬 Zagazig, Sharkia, Egypt