Using Letrozole to Treat Ectopic Pregnancy
Official title: Use of Letrozole in the Treatment of Early Ectopic Pregnancy
Run by Hospital de Clinicas de Porto Alegre · NCT06354439 · Data updated 2026-11-12
This study is testing if a daily pill called letrozole can effectively treat early ectopic pregnancies just as well as the usual shot of methotrexate.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 130 (estimated) |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Status | Recruiting |
| Started | March 27, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 9, 2024 |
| Trial ID | NCT06354439 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a diagnosis of early ectopic pregnancy who are hemodynamically stable and desire to preserve their reproductive options.
✕Probably not a fit
Patients with significant abdominal pain, abnormal liver or renal function, or those who have shown a significant decrease in hCG levels prior to randomization may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of oral letrozole, administered at a dose of 10mg per day for 7 days, in treating early cases of ectopic pregnancy. It is a multicenter, randomized trial comparing letrozole to the standard treatment of intramuscular methotrexate. The study aims to determine if letrozole is non-inferior to methotrexate in managing hemodynamically stable women diagnosed with tubal ectopic pregnancy. Participants will be monitored for their response to treatment and any potential side effects.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more convenient option for women with ectopic pregnancies.
How similar studies have gone: While methotrexate is a well-established treatment for ectopic pregnancy, the use of letrozole is relatively novel and has not been extensively tested in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil Recruiting
Study contacts
- Study coordinator: Ricardo F Savaris, MD, PhD
- Email: rsavaris@hcpa.edu.br
- Phone: +55 51 997781966
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Doppler ultrasound to predict success of conservative or methotrexate treatment for tubal ectopic pregnancy
This project will test whether specific Doppler blood-flow measurements at diagnosis can help predict if conservative management or methotrexate will successfully treat tubal ectopic pregnancy.
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PTSD after ectopic pregnancy
This project will test how common PTSD symptoms are in women who have had an ectopic pregnancy by asking them to complete brief questionnaires.
-
Methotrexate for ectopic pregnancy in patients with relative contraindications
This review will see if methotrexate worked safely and effectively for women with ectopic pregnancy who had conditions that make the drug relatively risky.
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vNOTES versus laparoscopic salpingectomy for ectopic pregnancy
This trial tests whether vNOTES or conventional laparoscopic salpingectomy gives faster recovery, less postoperative pain, and similar safety for women aged 18–55 who need surgery for ectopic pregnancy.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.