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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05198141
Other study ID # LETROZOLE ON ECTOPIC PREGNANCY
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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