Use of Letrozole for Ectopic Pregnancy

Phase 4

Recruiting

• Conditions: Ectopic Pregnancy
• Interventions: Drug: Methotrexate Sodium; Drug: Letrozole tablets

• Registration Number: NCT06354439
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate

Detailed Description

This is a multicenter randomized clinical trial on the use of letrozole in the medical treatment of tubal ectopic pregnancy. Tubal ectopic pregnancy is an abnormal pregnancy in the fallopian tube. They occurred in about 8% of all pregnancies presenting to the emergency department. Methotrexate (MTX), administered systemically (intramuscularly), is a widely used medication for the treatment of unruptured tubal ectopic pregnancies and has been recommended as first-line treatment for early cases of ectopic pregnancy.

Letrozole is an aromatase inhibitor and can suppress estradiol levels. Some recent studies have shown that its use can be applied in cases of ectopic pregnancy.

The aim of this non-inferiority clinical trial is to verify that letrozole treatment is non-inferior to methotrexate treatment in women with early ectopic pregnancy who are hemodynamically stable.

Study Timeline

• Study Start: 2024-03-27
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• 18 years or older
• Diagnosis of ectopic pregnancy
• Desire for reproduction
• Ease of return
• Undetermined pregnancy location with abnormal hCG growth
• Presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hCG level ≤ 3000 mIU/ml
• Absence of fetal cardiac activity
• Average diameter of the adnexal mass ≤ 3.5 cm
• Hemodynamically stable
• No significant abdominal pain (i.e, < 6 on a visual analog scale)

Exclusion Criteria

• Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician)

• Allergy to methotrexate or letrozole

• A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or

  ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization

• Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)

• Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min)

• Hemoglobin <10 g/dl

• Platelets <120.000/ml

• Presence of heterotopic pregnancy

• Do not wish to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate Sodium	Patients will receive a single intramuscular dose of 100 mg of methotrexate.
letrozole	Letrozole tablets	Patients will receive 10mg of letrozole por 7 days.

Primary Outcome Measures

Name	Time	Method
levels of beta fraction of human chorionic gonadotropin (beta-hCG)	weekly after the first day of intervention until reaching levels of beta-hCG below 5 milli-International unit per milliliter (assessed up to 5 months)"	On day 4 (D4) and 7(D7), beta-hCG levels will be measured. If a reduction equal or above 15% between D4 and D7 were observed, serum beta-hCG will be measured until reach levels \< 5 milli-International unit per milliliter (mIU/ml).

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil