Use of Letrozole for Ectopic Pregnancy (EcZOL)

Hospital de Clinicas de Porto Alegre

Status and phase: Enrolling; Phase 4

Conditions: Ectopic Pregnancy

Treatments: Drug: Letrozole tablets; Drug: Methotrexate Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT06354439

77015224.6.1001.5327

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

letrozole

Experimental group

Description:

Patients will receive 10mg of letrozole por 7 days.

Treatment:

Drug: Letrozole tablets

Methotrexate

Active Comparator group

Description:

Patients will receive a single intramuscular dose of 100 mg of methotrexate.

Treatment:

Drug: Methotrexate Sodium