Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

Assessment of the Efficacy of Letrozole in Comparison to Methotrexate in the Treatment of Ectopic Pregnancy

In this study, about 150 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment.

The level of antimullerin hormone is measured on the first day and 3 months after the treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Ectopic Pregnancy
• Intervention / Treatment: Drug: methotrexate; Drug: Letrozole

Detailed Description

In this study, about 150 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment.

The level of antimullerin hormone is measured on the first day and 3 months after the treatment.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Imam Khomeini Hospital Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women between 18-40 years of age who have spontaneously conceived and ectopic pregnancy has been definitively diagnosed.

Exclusion Criteria:

• B-HCG levels more or equal to 5000
• Hemoglobin level less than 10 g/dl Platelet level less than 100,000
• Increasing the level of liver function tests and the level of urea and creatinine The presence of fetal heart activity in the gestational sac

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: methotrexate; The first group will receive a single dose (50 mg/m2) of methotrexate The beta-hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.	Drug: methotrexate; methotrexate
Experimental: Letrozole BD; The first group will receive letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.	Drug: Letrozole; assessment of the efficacy of Letrozole in treatment of ectopic pregnancy
Experimental: Letroozole TDS; letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.	Drug: Letrozole; assessment of the efficacy of Letrozole in treatment of ectopic pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
βhCG	on day 14
Anti mulerian hormone	3 months

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Chair: azadeh tarafdari, Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): May 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy, Ectopic; Cardiac Complexes, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Letrozole; Methotrexate
• Other Study ID Numbers: IR.TUMS.IKHC.REC.1401.093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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