Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

NCT ID: NCT05198141

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-01-01

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.

Conditions

Ectopic Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group I (GI)

Patients who were undergoing surgical treatment

Group Type: ACTIVE_COMPARATOR

laparoscopic salpingectomy

Intervention Type: PROCEDURE

laparoscopic salpingectomy

low dose letrozole group II (GII)

patients who were medically treated with 5 mg of letrozole

Group Type: EXPERIMENTAL

Letrozole tablets

Intervention Type: DRUG

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)

High dose letrozole group (GIII)

patients who were medically treated with 10 mg of letrozole using

Group Type: EXPERIMENTAL

Letrozole tablets

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

laparoscopic salpingectomy

laparoscopic salpingectomy

Intervention Type: PROCEDURE

Other Intervention Names

Femara

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed Ali Alabiad, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed I Heraiz, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Mohamed ALI Alabiad

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Study Documents

Document Type: Study Protocol

you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com

View Document

Document Type: Statistical Analysis Plan

you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com

View Document

Document Type: Informed Consent Form

you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com

View Document

Document Type: Individual Participant Data Set

you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com

View Document

Other Identifiers

LETROZOLE ON ECTOPIC PREGNANCY

Identifier Type: -

Identifier Source: org_study_id