Evaluation of Different Doses of Letrozole in Ectopic Pregnancy (letrezole)

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

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.

Study Overview

• Status: Completed
• Conditions: Ectopic Pregnancy
• Intervention / Treatment: Procedure: laparoscopic salpingectomy; Drug: Letrozole tablets

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 14150
      • Mohamed ALI Alabiad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Ahmed I Heraiz, MD, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): November 20, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 15, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Ectopic pregnancy; Induced abortion; LETREZOLE
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: LETROZOLE ON ECTOPIC PREGNANCY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Table Statistical analysis Master sheet raw data (excel sheet)
• IPD Sharing Time Frame: the data will become available after one month from the approval and will be available for three months
• IPD Sharing Access Criteria: you can send a Data request email to Dr: Mohamed at drno99@yahoo.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. Study Protocol
   Information comments: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
2. Statistical Analysis Plan
   Information identifier: drno99@yahoo.com
   Information comments: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
3. Informed Consent Form
   Information comments: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com
4. Individual Participant Data Set
   Information comments: you can send a Data request e-mail to Dr Mohamed at drno99@yahoo.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No