Use of Letrozole for Ectopic Pregnancy

Recruiting now · Phase 4

Conditions studied: Ectopic Pregnancy

In brief

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

Key facts

Study ID

NCT06354439

Run by

Hospital de Clinicas de Porto Alegre

People needed

130

Starts

2024-03-27

Expected to finish

2026-12-31

Last updated by the study team

2024-04-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)

Full record on ClinicalTrials.gov

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