NCT06354439

Use of Letrozole for Ectopic Pregnancy

Use of Letrozole in the Treatment of Early Ectopic Pregnancy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ectopic Pregnancy

Interventions

Type	Name	Description
DRUG	Letrozole tablets	10 mg of letrozole PO for 7 days
DRUG	Methotrexate Sodium	100 mg of methotrexate IM, single dose

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: Brazil