RecruitingPhase 4NCT06354439

Use of Letrozole for Ectopic Pregnancy

Use of Letrozole in the Treatment of Early Ectopic Pregnancy

Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

130 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

Ectopic Pregnancy

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

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 Criteria10

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.

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