Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

Ectopic Pregnancy Clinical Trial

— letrezole  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198141
• Other study ID #: LETROZOLE ON ECTOPIC PREGNANCY
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2022
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

Inclusion Criteria:

• Diagnosed ectopic pregnancy was by

• Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with

• ß-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

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Drug:
• Letrozole tablets
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)

Procedure:
• laparoscopic salpingectomy
laparoscopic salpingectomy

Locations

Country	Name	City	State
Egypt	Mohamed ALI Alabiad	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ß-hCG level	A quantitative human chorionic gonadotropin	The ß-hCG levels were assessed on the 1st of treatment
Primary	ß-hCG level	A quantitative human chorionic gonadotropin	The ß-hCG levels were assessed on the 11th day of treatment
Secondary	Complete blood count (CBC)	Complete blood count	Assessed on the 1st day of treatment
Secondary	Alanine Amino Transferase (ALT)	Liver enzyme	Assessed on the 1st and 11th day of treatment
Secondary	Aspartate aminotransferase (AST)	Liver enzyme	Assessed on the 1st and 11th day of treatment
Secondary	Serum creatinine	Renal function test	Assessed on the 1st and 11th day of treatment
Secondary	Blood urea	Renal function test	Assessed on the 1st and 11th day of treatment
Secondary	Complete blood count (CBC)	Complete blood count	Assessed on the 11th day of treatment
Secondary	Alanine Amino Transferase (ALT)	Liver enzyme	Assessed on the 11th day of treatment
Secondary	Aspartate aminotransferase (AST)	Liver enzyme	Assessed on the 11th day of treatment
Secondary	Serum creatinine	Renal function test	Assessed on the 11th day of treatment
Secondary	Blood urea	Renal function test	Assessed on the 11th day of treatment