Use of Letrozole for Ectopic Pregnancy

Last updated: April 5, 2024
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

4

Condition

Pregnancy

Treatment

Methotrexate Sodium

Letrozole tablets

Clinical Study ID

NCT06354439
77015224.6.1001.5327
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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 tubalectopic 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

Exclusion Criteria:

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

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Methotrexate Sodium
Phase: 4
Study Start date:
March 27, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, RS 90035-903
    Brazil

    Active - Recruiting

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